Surgical Gloves
Sterile Latex Surgical Gloves Powdered (Sterile Pre-powdered – Type 1)
Available Sizes
Size Chart
5.5
6
6.5
7
8
8.5
9
Product Details
- Gloves compounded primarily from natural rubber latex (Type-1).
- Creamy white to pale yellow in colour (Natural colour).
- Free from dirt marks, oil stains, embedded foreign particles, coagulum, etc.
- EO Sterilized.
- Product conforms to IS 13422:1992 , ASTM D 3577:2019 , EN 455-1:2000 ,EN 455 2:2009+A2 : 2013 , EN 455-3:2006 and EN 455-4:2009 standard specifications.
- Anatomically shaped medical gloves with the thumb positioned towards the palmar surface of the Index finger rather than laying flat.
- Lightly powdered with modified absorbable Corn Starch USP .
- The cuff shall fit closely without being constrictive and 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 5 years from the date of manufacturing.
- Each glove has non-detectable levels of chemical residue.
- Sterilized by validated process cycle as per ISO 11135:2014.
- Passes Viral Penetration test as per ASTM F 1671
- The Sterility Assurance Level (SAL) is 10−6.
- Biologically compatible as per ISO 10993-Part 5,7, 10 & 11.
- Nontoxic, non-irritant and non-pyrogenic.
- Gloves intended for use in surgical work and to be worn once and then discarded. The glove is worn on the hand of surgeon and healthcare 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 to be used in conjunction with invasive surgery.
- Store the gloves in a cool, dry place and away from direct sunlight.
- Sterile Gloves for single use only. Sterile until package is opened or damaged.
- This product contains natural rubber latex which may cause allergic reactions including anaphylactic responses in some individuals.
- After donning, remove powder by wiping gloves thoroughly with a sterile wet sponge, sterile wet towel, or other effective method.
- Reuse of gloves may cause infection, allergic reactions, 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.
| Size | Length (mm) | Palm Width (mm) | Thickness ( in mm) | |||||
|---|---|---|---|---|---|---|---|---|
| Cuff (Min) | Palm (Min) | Finger (Min ) | ||||||
| Min | Specification | Standard | SMR | Standard | SMR | Standard | SMR | |
| 5½ | 250 | 70 ± 6 | 0.10 | 0.11 | 0.10 | 0.14 | 0.10 | 0.16 |
| 6 | 265 | 76 ± 6 | ||||||
| 6 ½ | 83 ± 6 | |||||||
| 7 | 270 | 89 ± 6 | ||||||
| 7 ½ | 95 ± 6 | |||||||
| 8 | 102 ± 6 | |||||||
| 8 ½ | 280 | 108 ± 6 | ||||||
| 9 | 114 ± 6 | |||||||
2. Physical Properties
| Characteristics | Before Ageing | After Ageing 70 ± 20 °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 455-2:2009+A2:2013 | ||
| Minimum force at break | 9.0 N | 9.0 N |
| Aqueous extractable protein content (As per standards ASTM D 3577:2019 & EN 455-3:2006) |
< 200 μg/dm² – Test method ASTM D 5712-15 (2020) | |
| Powder content (As per standards ASTM D 3577:2019 & EN 455-3:2006) | < 15 mg/dm² - Test method ASTM D 6124-06 (2017) | |
| Sterilization (for sterile product) | Ethylene Oxide | |
| Sterility | Shall pass Sterility test as per IP /USP / EN standards | |
|
Packing Packing type: |
Shall comply with standard packaging and customer requirements |
|
| Labeling |
Shall comply with regulatory requirement and customer requirements |
|
3. Performance Requirements as per ASTM D 3577:2019 & EN 455-1; 2000, EN 455-2:2009+A2:2013 & EN 455-3: 2006
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)
| Characteristics | Inspection Level | AQL |
|---|---|---|
| Freedom from holes | G-1 | 0.65 |
| Physical Dimensions | S2 | 4.0 |
| Physical Properties | S2 | 4.0 |
| Extractable Protein Content | N=3 | NA |
| Powder amount | N=3 | NA |
| Sterility | As per standard | N/A |
Sterile Latex Surgical Gloves Powdered (Sterile Pre-powdered – Type 1)
Size Chart
Surgical Gloves
Sterile Latex Surgical Gloves Powdered (Sterile Pre-powdered – Type 1)
| Inches | CM |
|---|---|
| 5.5 | 14 |
| 6 | 15 |
| 6.5 | 17 |
| 7 | 18 |
| 7.5 | 19 |
| 8 | 20 |
| 8.5 | 22 |
| 9 | 23 |
| 9.5 | 24 |
How to measure yourself
Purpose: To ensure free from any chemical substances and safe to use any chemical substances and safe to.
