‘Surgicare Plus’ Sterile Powder free Chlorinated Sterile Latex Surgical Gloves for all Surgeries
Surgicare Plus is made from Natural Rubber Latex. The powder free gloves, eliminates all risks associated with powder. The glove is anatomically shaped with thumb ball effect, reducing hand fatigue during surgical procedures. Surgicare Plus provides excellent barrier protection for both doctor and patient.

Safety Features
  • 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
  • Absence of powder eliminates dangers associated with powder, preventing granulomas, adhesions, fibrosis and occupational asthma. Does not contaminate sterile work area.
  • Latex film structure passes Viral penetration Test (ASTM F1671:2007)
  • Manufactured in clean environment to achieve bio burden level of less than 20 cfu prior sterilization. This achieves low Pyrogen level after sterilization.
  • Manufacturedin a clean environment to comply with EN 556 & ISO 13485 requirements.
  • Sterilized in a validatedprocess cycle to achieve sterility assurance levelof let,and air wash cycles to reduce sterilant residue to less than 4mg/unit.


Standards
  • ASTM : D-3577-2009 & EN 455-1:2000, EN 455-2:2015 and EN 455-3:2015,EN 455-3:2015 & ISO 10282:2014
  • Registered with US FDA (510K)
  • CE Mark - MOD Class lla / PPE Cat.Ill


Quality Control
  • 100% Inspected
  • Passes Viral Penetration Test - ASTM F 1671:2007
  • Factory Standard of0.65 AQL for Pinholes


Product Information
  • TYPE: Powder Free Chlorinated Latex Surgical Gloves.
  • PRIMARY MATERIAL: Natural Rubber Latex(NR).
  • COLOUR: Natural White to Light yellow.
  • 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: 3 Years inoriginalpackaging if stored as per storage


PHYSICAL DIMENSIONS

Size

Length

(mm) Min

Palm Width

(mm) Min

Thickness (mm) Min

Cuff

Palm

Finger

250

72±4

0.14

0.17

0.19

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

NA

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: 1,15,600 pairs/40FCL: 3,96,000 pairs



» Product Specification of ‘Surgicare Plus’ Sterile Powder free Chlorinated Sterile Latex Surgical Gloves