'Surgicare Premier' Excellent Polymer Coated Powderfree Surgical gloves
Surgicare Premier is made from Natural Rubber Latex. The glove is anatomically shaped with thumb ball effect, reducing hand fatigue during surgical procedures. Polymercoated Surgicare provides excellent barrier protection for both doctor and patient.

Safety Features
  • Enhanced elasticity, tear strength and donning of powderfree gloves.
  • Latex protein no more than 50µg of protein per dm2, eliminates risk of Latex Allergy – Type 1.
  • Inner Polymer Coating provides smooth and easy donning of gloves
  • Chemical residue almost nil, eliminates risk of Contact Dermatitis – Type IV Allergy
  • Micro textured surface for excellent instrument grip and anti­ slip finish.
  • Sterilized in a validated process cycle as per ISO 11135:2014 norms SAL 10-6.
  • Absence of powder eliminates dangers associated with powder, preventing granulomas, adhesions, fibrosis and occupational asthma. Does not contaminate sterile work area.
  • Manufacturedina cleanenvironment to comply with EN 556 & ISO13485requirements
  • Manufactured in dust free enviornment with low bioburden and therefore reduced pyrogen.


Standards
  • EN 455-I:2000, EN 455-II:2015, EN 455-III:2015, ASTM D 3577:2009& ISO 10282:2014
  • CE Mark- MOD Class lla / PPE cat.Ill
  • Registered with USFDA (510K)
  • Passes Biocompatibility test as per ISO 10993-10


Quality Control
  • 100% Inspected
  • Passes Viral Penetration Test - ASTM F 1671:2007
  • Factory Standard of AQL 0.65 for Pinholes


Product Information
  • TYPE: Powder Free Polymer Coated Latex Surgical Gloves.
  • PRIMARY MATERIAL: Natural Rubber Latex(NR).
  • COLOUR: NaturalWhite
  • DESIGN: Hand Specific, Curved finger, Beaded cuff, Micro rough textured.
  • POWDER FREE RESIDUE: < 2 mg/glove
  • STERILIZATION: Ethylene Oxide / Gamma as per Customer requirement.
  • SHELF LIFE: 5 Years InoriginalpackagingIf stored as per storage instructions.


PHYSICAL DIMENSIONS

Size

Length

(mm) Min

Palm Width

(mm) Min

Thickness (mm) Min

Cuff

Palm

Finger

250

72±4

0.13

0.16

0.16

6

280

77±5

83±5

7

89±5

95±5

8

102±6

108±6

9

114±6


PHYSICAL PROPERTIES

Characteristics

Before

Ageing

After Ageing
70±2°C for 166±2 hrs

Tensile Strength (Mpa) min.

24

18

Ultimate Elongation (%) min.

750

560

Stress at 500% Elongation (Mpa) Max.

5.5

-

Force at break (N) Min.

9.0

9.0


Pre-Shipment Quality Inspection
Sampling Procedure: ISO 2859 Part I
Sampling Plan: Single sampling, Normal Inspection

Characteristics

Inspection

Level

AQL

Freedom from Holes

G-1

1.5

Visual attributes - Major Defects

G-1

1.5

Visual attributes - Minor Defects

G-1

2.5

Physical Dimension

S-2 / N=13

4.0

Physical Properties

S-2

4.0

Force at break

N=13

N/A

Extractable Protein Content

N=3

N/A

Powder free residue

N=5

N/A

Sterility

N=5

N/A



packaging

Material

Quantity

Dimension (cm)

Paper Wallet

One Pair

19(L) x 10(W)

Pouch

One Pair

26(L) x 13(W)

Inner Box

50 Pairs

26(L) x 13(W) x 20(H)

Master Carton

400 Pairs

53(L) x 27(W) x 41(H)

Container Quantities

20FCL: 1,87,600 pairs/40FCL: 3,96,000 pairs



» Product Specification of ‘Surgicare Premier’