Surgicare Premier
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.
  • Chemical residue almost nil, eliminates risk of Contact Dermatitis – Type IV Allergy
  • Sterilized in a validated process cycle as per ISO 11135:2007 norms.
  • Absence of powder eliminates dangers associated with powder, preventing granulomas, adhesions, fibrosis and occupational asthma. Does not contaminate sterile work area.
  • Manufactured in dust free enviornment with low bioburden and therefore reduced pyrogen.


Standards
  • EN 455-I:2000, EN 455-II:2011, EN 455-III:2006 & ASTM D 3577:2009
  • CE Certified
  • Registered with USFDA (510K)


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


Product Information
  • TYPE: Powder Free Polymer Coated Latex Surgical Gloves. Sterilized by ETO.
  • PRIMARY MATERIAL: Natural Rubber Latex.
  • DESIGN: Hand Specific, Curved finger, Beaded cuff, Micro rough textured.
  • POWDER FREE RESIDUE: < 2 mg/glove
  • STERILIZATION: Ethylene Oxide / Gamma as per Customer requirement.


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 (for sterile product)

N=5

N/A



packaging

Material

Quantity

Dimension (cm)

Paper Wallet

One Pair

20(L) x 11.5(W)

Pouch

One Pair

27(L) x 15(W)

Inner Box

50 Pairs

27(L) x 15(W) x 21(H)

Master Carton

400 Pairs

62(L) x 28.5(W) x 44(H)

Container Quantities

20FCL: 1,15,800 pairs/40FCL: 3,16,000 pairs



» Product Specification of ‘Surgicare Premier’