Disposable Sterile Latex Gynaecological Gloves –Powder Free (Polymer Coated)

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Available Sizes

Size Chart

6.5

7.5

Product Details

Gloves compounded primarily from natural rubber latex (Type-1).
Powder-free gloves coated with a unique blend of polymer to provide excellent donning capability.
Creamy white to pale yellow in colour (Natural).
Excellent barrier protection due to its extra length preventing cross contamination.
Free from dirt marks, oil stains, embedded foreign particles, coagulum, etc.
EO sterilized

Anatomically shaped medical gloves with the thumb positioned towards the palmar surface of the index finger rather than laying flat.
The cuff shall fit closely without being constrictive, and it shall not roll back or ruckle while in use.
Anatomically shaped with micro rough surface in palm and finger area.
Products have shelf-life of 3 years from the date of manufacturing
Each glove has non- detectable level of chemical residue.
Sterilized by validated process.
Passes Viral Penetration test as per ASTM F 1671
Biologically compatible as per ISO 10993-Part 5 ,7,10 &11
Passes Bacterial Endotoxin test as per EN 455-3:2015
Manufactured in hygienic environment to reduce bio burden level prior to sterilization.

Keep the gloves in cool, dry place and away from direct sun light.
Sterile Gloves for single use only. Sterile until package is opened or damaged.
This product contains natural rubber latex which may cause allergic reaction to some individuals. In case of latex allergy discontinues use and consults a physician.
Reuse of gloves may cause infection, allergic reaction and poor barrier protection.
For transient use (normally intended for continuous use for less than 60 minutes)
Dispose after use as per hospital policies or country’s regulatory norms.

Gloves intended to be worn once and then discarded. The glove is worn on the hand of surgeon and health care personnel to prevent cross contamination between healthcare personnel and patient’s body, fluids, waste or environment. The gloves are designed for transient use and are intended for gynaecological and obstetrical use.

Size		Length (mm) min	Width (mm) min	Thickness (mm) min
Size		Length (mm) min	Width (mm) min	Finger	Palm	Cuff
6½	14 inch	350 mm	83 ± 5	0.18	0.16	0.11
	16 inch	400 mm
	18 inch	450 mm
7½	14 inch	350 mm	95 ± 5	0.18	0.16	0.11
	16 inch	400 mm
	18 inch	450 mm
8½	14 inch	350 mm	108 ± 6	0.18	0.16	0.11
	16 inch	400 mm
	18 inch	450 mm

Characteristics	Before Ageing	After Ageing (70 ± 2° C for 168 hrs)
ASTM D 3577:2019, IS 13422:1992
Tensile Strength (Mpa) min.	24	18
Ultimate Elongation (%) min.	750	560
Stress at 500% Elongation (Mpa) Max.	5.5	NA
EN 455-2:2015
Minimum force at break	9.0 N	9.0 N

Sterilization (for sterile product)	Ethylene Oxide
Sterility	Shall pass Sterility test as per US/ IP/EU Pharmacopeia
Packing Packing type: 1 Pair (1 left and 1 right) of gloves per inner wrapper. 1 inner wrapper per pouch. 25 pouches per inner (dispenser) box. 8 dispenser box( 200 pairs) in an outer carton	Shall comply with standard packing and customer requirements
Labeling	Shall comply with government regulatory requirement for and customer requirements

Sampling procedure:
ISO 2859 Part-I

Sampling plan:
i. General Inspection Level – For freedom from pinholes
ii. Special Inspection Level – For Physical Dimension and Physical Properties (Before ageing and after ageing)