EDMAGroup

Safe Plus

Nitrile Examination Gloves

Protection you can rely on. Always.

NitrileCE 28652 variants22 standards
29Chemotherapy drugs on the permeation panel
3,000,000Gloves in a 40ft HC container
3 yrsShelf life from manufacture date
Safe Plus nitrile gloves, retail box and carton
01 · The lineCE 2865

What this glove is for

Most gloves are sold on the price per box. This one is sold on what passes through it — and what does not.

Safe Plus is a powder-free nitrile examination glove made for people whose hands are their working day — medical and dental teams, laboratories, food service, tattoo studios and salons. Micro-textured fingertips give grip in wet or dry work without giving up tactile feel, and the fit is tuned to reduce hand fatigue across a full shift.

It is also the line the rest of this page has to answer for: chemotherapy-permeation tested under ASTM D6978-05, FDA 510(k) cleared under K211547, CE marked, and manufactured under EN ISO 13485 with random batch testing — with certification issued per line and per lot, supplied with every quote.

Safe Plus — the fit — second-skin, ambidextrous
Comfortable, anti-fatigueLong shifts stop being the limiting factor — the fit reduces hand fatigue and overheating.
Extra stretchElongation and tensile balance tuned so the glove stretches without breaking or leaking.
Verified barrier performancePublished testing covers chemotherapy-drug permeation, blood-borne pathogens and freedom from holes.
02 · The format

What you are holding

AmbidextrousDesigned to fit either hand, so a box is never half-useful.
Finger texturedMicro-roughened fingertips for grip in wet or dry work, without losing tactile sensitivity.
Powder-freeNo donning powder: less sweat, less irritation, and nothing to contaminate a work surface.
Non-sterile and sterileBoth variants run on the same line and specification — the sterile version is individually packed.
Safe Plus — stretch test — 550% elongation minimumStretch test — 550% elongation minimum
Safe Plus — puncture resistance — tensile balancePuncture resistance — tensile balance
Safe Plus — liquid barrier — fluid protectionLiquid barrier — fluid protection
03 · Permeation testing

Tested against 29 chemotherapy drugs

ASTM D6978-05 — the standard practice for assessing resistance of medical gloves to permeation by chemotherapy drugs.

drugs on the panel

Twenty-seven of the twenty-nine drugs were not detected through the glove at all over four hours of continuous contact. Two — Carmustine and ThioTEPA — broke through inside sixty minutes, and they are published here with their measured rates rather than omitted. A result you can check is worth more than a list with the failures removed.

Industry-standard panel
DRUGCONCENTRATIONBREAKTHROUGHµg/cm²/min
Cisplatin1 mg/ml (1,000 ppm)Not detected to 240 minN.D.
Cyclophosphamide (Cytoxan)20 mg/ml (20,000 ppm)Not detected to 240 minN.D.
Dacarbazine10 mg/ml (10,000 ppm)Not detected to 240 minN.D.
Doxorubicin HCl2 mg/ml (2,000 ppm)Not detected to 240 minN.D.
Etoposide20 mg/ml (20,000 ppm)Not detected to 240 minN.D.
5-Fluorouracil50 mg/ml (50,000 ppm)Not detected to 240 minN.D.
Ifosfamide50 mg/ml (50,000 ppm)Not detected to 240 minN.D.
Mitoxantrone2 mg/ml (2,000 ppm)Not detected to 240 minN.D.
Paclitaxel6 mg/ml (6,000 ppm)Not detected to 240 minN.D.
Vincristine Sulfate1 mg/ml (1,000 ppm)Not detected to 240 minN.D.
Carmustine (BCNU)3.3 mg/ml (3,300 ppm)Detected in under 60 min0.7
ThioTEPA10 mg/ml (10,000 ppm)Detected in under 60 min0.7
Additional EDMA panel
DRUGCONCENTRATIONBREAKTHROUGHµg/cm²/min
Bleomycin Sulfate15 mg/ml (15,000 ppm)Not detected to 240 minN.D.
Busulfan6 mg/ml (6,000 ppm)Not detected to 240 minN.D.
Carboplatin10 mg/ml (10,000 ppm)Not detected to 240 minN.D.
Cytarabine HCl100 mg/ml (100,000 ppm)Not detected to 240 minN.D.
Daunorubicin HCl5 mg/ml (5,000 ppm)Not detected to 240 minN.D.
Docetaxel10 mg/ml (10,000 ppm)Not detected to 240 minN.D.
Ellence2 mg/ml (2,000 ppm)Not detected to 240 minN.D.
Fludarabine25 mg/ml (25,000 ppm)Not detected to 240 minN.D.
Gemcitabine38 mg/ml (38,000 ppm)Not detected to 240 minN.D.
Idarubicin1 mg/ml (1,000 ppm)Not detected to 240 minN.D.
Irinotecan20 mg/ml (20,000 ppm)Not detected to 240 minN.D.
Mechlorethamine1 mg/ml (1,000 ppm)Not detected to 240 minN.D.
Melphalan5 mg/ml (5,000 ppm)Not detected to 240 minN.D.
Methotrexate25 mg/ml (25,000 ppm)Not detected to 240 minN.D.
Mitomycin C0.5 mg/ml (500 ppm)Not detected to 240 minN.D.
Rituximab10 mg/ml (10,000 ppm)Not detected to 240 minN.D.
Trisenox1 mg/ml (1,000 ppm)Not detected to 240 minN.D.

N.D. — not detected. Other observation recorded during testing: slight swelling, no impairment. Full test reports are supplied with the certification pack.

04 · Specification

The full sheet

The table a procurement team needs before it can raise an RFQ — sizes, thicknesses, tolerances and the AQL.

Available sizesS (6.5–7) · M (7.5–8) · L (8.5–9) · XL (9.5–10)
MaterialNitrile — latex free
ColourBlue · Black · Purple · Pink · Green
Powder statusPowder free
External surfaceFully textured
Cuff lengthStandard, beaded
Palm thickness0.09 mm / 3.5 mil
Finger thickness0.12 mm / 4.7 mil
Glove length240 mm / 9.5 in (min, ±5)
Width by sizeS: 80 · M: 95 · L: 110 · XL: 120 mm (±10)
Freedom from holesAQL 1.5 (inspection level 1) — non-sterile; AQL 1.0–1.5 sterile
Allergy preventionLatex Type 1 — no natural rubber protein
Tensile strength27 MPa/min before ageing; 27 MPa/min after
Elongation at break550% min before ageing; 500% min after
Shelf life3 years from the manufacture date printed on each box
Powder residueASTM D-6124-06 — result below 2.0 mg/dm²
Material compositionPure nitrile rubber
CleaningWashable with isopropyl alcohol
SuitabilityHealthcare and the food industry
SegmentationMultipurpose — medical, dental, food, laboratory, tattoo, beauty
Safe Plus retail boxAs shipped · CE 2865
05 · Variants

Non-sterile and sterile

Same line, same specification — the sterile variant is individually packed and inspected to its own AQL.

Powder-free, Non-Sterile

Nitrile Examination GlovesSafe Plus powder-free, non-sterile

Safe Plus non-sterile nitrile examination gloves are intended for single-use, non-surgical medical procedures and examinations. A fully textured finish supports wet or dry grip where dexterity and tactile sensitivity are required.

Width (mm) (±10)S: 80 M:95 L:110 XL:120
Length (mm)Min 240mm ± 5
Thickness (Palm + Finger)0.12mm ± 0.02mm, Comparable to 4 mil glove
Before AgingTensile Strength 27 MPa / min Elongation at Break (%) 550% min
After (70 ± 2°C for 166 ± 2 hrs)Tensile Strength 27 MPa / min Elongation at Break (%) 500% min
Box size23.3 × 12.3 × 6.3 cm
Carton size33.5 × 25.8 × 24.8 cm

Powder-free, Sterile

Nitrile Sterile Examination GlovesSafe Plus powder-free, sterile

Safe Plus sterile nitrile examination gloves are individually packed for single-use procedures that require a sterile barrier. They combine high tensile strength with the tactile feel, sensitivity and control needed for precise clinical work.

Width (mm) (±10)S: 80 M:95 L:110 XL:120
Length (mm)Min 240mm ± 5
Thickness (Palm + Finger)0.12mm ± 0.02mm, Comparable to 4 mil glove
Before AgingTensile Strength 27 MPa / min Elongation at Break (%) 550% min
After (70 ± 2°C for 166 ± 2 hrs)Tensile Strength 27 MPa / min Elongation at Break (%) 500% min
Box size54 x 27 x 41 cm
Carton size
06 · Colourways

5 colourways across the line

Colour is specified by variant and production run; the packaging carries the colourway.

Safe Plus in blueBlue
Safe Plus in blackBlack
Safe Plus in purplePurple
Safe Plus in pinkPink
Safe Plus in greenGreen
07 · Packing

Box, carton, container

The packing math a buyer needs to size an order — from a single box to a full 40ft high-cube.

100Gloves per box
1,000Per master carton — 10 × 100
3,000,000Gloves per 40ft HC — 30,000 boxes
Gloves per box100 (non-sterile) · 50 individually packed pairs (sterile)
Box size23.3 × 12.3 × 6.3 cm
Carton size33.5 × 25.8 × 24.8 cm
Sterile box size54 × 27 × 41 cm
Box, imperial9.17 × 4.84 × 2.48 in
Carton, imperial13.1 × 10.15 × 9.76 in
Master carton1,000 gloves — 10 boxes × 100
Carton weight5.4 kg / 11.9 lb
40ft HC container30,000 boxes — 3,000,000 gloves

Figures follow the product specification for the selected variant. Final packing configuration and any container fill are confirmed on the quote.

08 · Uses & applications

Where it is specified

Taken from the product documentation supplied with every quote.

USE 01Medical examinations and non-surgical clinical procedures
USE 02Dental treatment and instrument handling
USE 03Laboratory work and handling under the applicable chemical-safety protocol
USE 04Food preparation and hygienic handling
USE 05Tattoo, beauty and personal-care services
USE 06Professional cleaning, automotive and general industrial tasks
Safe Plus in use — medicalMedical
Safe Plus in use — dentalDental
Safe Plus in use — foodFood
Safe Plus in use — tattooTattoo
Safe Plus in use — beauty & spaBeauty & spa
Safe Plus in use — cleaningCleaning
Safe Plus in use — automotiveAutomotive

Product-in-environment renders of the actual retail box and glove — not stock photography.

APP 01Contact with blood, body fluids, mucous membranes or non-intact skin
APP 02Wound dressing, drain or suture removal and catheter-related care under the appropriate clinical protocol
APP 03Sterile dressing changes and other procedures where an individually packed sterile glove is specified
APP 04Handling clinical, dental or laboratory instruments
APP 05Work requiring reliable wet or dry grip and fine tactile control
09 · Properties

What the material does

01Pure nitrile construction with no natural-rubber latex protein.
02Fully textured surface for wet or dry grip without sacrificing tactile sensitivity.
03Elongation and tensile balance designed for stretch, puncture resistance and dependable fit.
04Second-skin feel that supports dexterity and reduces fatigue during extended wear.
05Barrier performance tested for freedom from holes, blood-borne pathogens, chemicals and chemotherapy-drug permeation.
10 · Certification

22 standards on file

Certificates are issued per line and per lot and supplied with every quote — not as a blanket family claim.

US FDA 510(k) K211547
US FDA 21 CFR 177
EN ISO 13485:2016
EN ISO 9001:2015
EN ISO 14971:2019
EN ISO 15223-1:2016
EN ISO 21420
EN ISO 374-1:2016+A1:2018
EN ISO 374-2:2014
EN ISO 374-4:2019
EN ISO 374-5:2016
EN 455-1:2000
EN 455-2:2015
EN 455-3:2015
EN 1186:2020
EN 16523-1:2015+A1:2018
EN 420:2003+A1:2009
ASTM D6319
ASTM D6978-05
ASTM F1671
ISO 10993-1 · -5 · -10
IEC 62366-1:2015(en)
US FDA 510(k) K211547Market clearance, powder-free nitrile examination gloves — the clearance number is on file and supplied with the certification pack.
ASTM D6978-05Assessment of resistance of medical gloves to permeation by chemotherapy drugs — the chemo-grade test.
ASTM F1671Resistance to penetration by blood-borne pathogens.
ASTM D6319The product standard for nitrile powder-free examination gloves.
EN 455-1 · -2 · -3Freedom from holes, physical properties, and biological evaluation for single-use medical gloves.
EN ISO 374-1 · -2 · -4 · -5Protection against chemicals and micro-organisms: permeation, penetration, degradation and viral protection.
EN ISO 13485:2016The quality management system standard governing the production line itself.
EN 1186:2020Materials in contact with foodstuffs — the food-safe rating.
IEC 62366-1:2015Usability engineering applied to medical devices.
The group audit register →
11 · Instructions for use

As printed on the pack

    Use and precautions
  • Always wash and dry your hands before putting the gloves on.
  • Check the packaging and the gloves for defects or damage.
  • Take the gloves from the box and put them on carefully, without excessive force or pulling.
  • Keep fingernails short and change gloves frequently, so protection against tears is not reduced.
  • Dispose of gloves after use in the appropriate waste containers, per local regulations.
    Storage and shelf life
  • Store in a cool, dry place, away from unnecessary sunlight, direct fluorescent light and aggressive agents.
  • Storage should be climate controlled, below 104°F (40°C).
  • Shelf life is three years from the manufacture date printed on each pack.
12 · How it is made

The line behind the box

Every EDMA factory is inspected thoroughly and audited regularly, with random batch testing, and compliance with international quality management systems is certified.

The gloves are produced using Safe Plus’s extended manufacturing process, developed for easier donning and removal without irritating the skin.

Alongside the quality, the line is manufactured efficiently — which is what makes competitive pricing and reliable delivery possible at volume.

13 · In summary

What makes Safe Plus different

01Pure nitrile, powder-free construction
02Non-sterile and individually packed sterile formats
03Twenty-nine-drug ASTM D6978-05 permeation panel published in full
04FDA 510(k) K211547 clearance and CE 2865 marking
05Five colourways on one core specification
06Inspected production with certification supplied per line and per lot
ORDER THIS LINE

Configure a production run.

An RFQ returns a costed quote within two business days — unit price, MOQ, packing configuration, container fill and lead time, with the certification scope for this line attached. Contracted orders run on TradeOS with a live portal.

Request a quote →Request a production quote

All fifteen brands →