LATEX EXAMINATION GLOVES (POWDER FREE)
Device Facts
| Record ID | K014279 |
|---|---|
| Device Name | LATEX EXAMINATION GLOVES (POWDER FREE) |
| Applicant | Brightway Gloves Pvt. , Ltd. |
| Product Code | LYY · General Hospital |
| Decision Date | Mar 20, 2002 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 880.6250 |
| Device Class | Class 1 |
Intended Use
Latex Examination Glove (Powder free) is a Powder free devices made of Natural Latex intended for medical purpose that is worn on the examiners hand or finger to prevent contamination between patient and examiner.
Device Story
Natural rubber latex examination glove; powder-free; worn on examiner's hand or finger; acts as physical barrier to prevent cross-contamination between patient and examiner; used in clinical settings; provides protection during medical examinations; disposable.
Clinical Evidence
Bench testing only. Device performance evaluated against ASTM D3578 requirements for length, width, thickness, tensile strength, and elongation at break (before and after ageing). Freedom from holes tested per FDA requirements. Protein content measured at 80 +/- 20 ppm; powder content at 1 +/- 1 mg/glove; moisture content at 0.8% max. Biocompatibility confirmed.
Technological Characteristics
Natural rubber latex; powder-free; dimensions and physical properties compliant with ASTM D3578; tensile strength 20-22 MPa (before ageing); elongation at break 750-850% (before ageing); protein content 80 +/- 20 ppm; moisture content 0.8% max; non-sterile.
Indications for Use
Indicated for use as a disposable medical glove worn on the examiner's hand or finger to prevent contamination between patient and examiner. No specific age or gender restrictions; contraindications include individuals with natural rubber latex allergies.
Regulatory Classification
Identification
A non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. A non-powdered patient examination glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.
Predicate Devices
- Class I Patient Examination Gloves Latex (Powder free) 80LYY (K014279)
Related Devices
- K993457 — POWDERFREE LATEX EXAMINATION GLOVES (PROTEIN LABEL CLAIM) [50 MICROGRAMS OR LESS] · Sri Johani Sdn. Bhd. · Dec 2, 1999
- K101106 — POWDERED, NATURAL COLOR, LATEX EXAMINATION GLOVE MODEL: MEP1 · Best Putra Gloves Sdn Bhd · Nov 10, 2010
- K123537 — POWDER FREE LATEX EXAMINATION GLOVES · Qube Medical Product Sdn Bhd · Feb 12, 2014
- K210253 — Best Glove-Latex Powder Free Examination Glove · Bestsafe Glove Co., Ltd. · Nov 5, 2021
- K973830 — POWDER FREE PATIENT EXAMINATION GLOVE SAFE GLOVE · Safe Glove , Ltd. · Jan 16, 1998
Submission Summary (Full Text)
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510K SUMMARY as required by: 807.92( c ) 1.0.
2.0 APPLICANT
92(c)
K014279
MAR 2 0 2002
PAGE NO- 56
NAME
ADDRESS
M/s. BRIGHTWAY GLOVES PVT.LTD.
PIONEER MANIKANDAN BUILDINGS. VADASERY, NAGERCOIL, TAMIL NADU,
INDID-629001.
91-4652- 276291 / 276046 . PH.NO.
FAX NO 91-4652- 274271 .
CONTACT PERSON MR. N.PARAMASIVAN MANAGING DIRECTOR. 3. DEVICE TRADE NAME : NIL COMMON NAME : Latex Examination Glove (Powder free)
4. Legally marketed device to which the company claiming equivalence: Class I Patient Examination Gloves Latex (Powder free) 80L Y Y that meets all the requirements of ASTM D3578.
5. DESCRIPTION OF THE DEVICE:
Class I Patient Examination Gloves Latex (Powder free) 80L Y Y that meets all the requirements of ASTM D3578
6. Intended use of the Device:
Latex Examination Glove (Powder free) is a Powder free devices made of Natural Latex intended for medical purpose that is worn on the examiners hand or finger to prevent contamination between patient and examiner.
Image /page/0/Picture/15 description: The image shows a circular stamp with the words "BRIGHTWAY GLOVES PVT. LTD." written around the outer edge of the circle. Inside the circle, the word "NAGERCOIL" is written in bold letters. There is a star symbol at the bottom of the stamp.
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### PAGE NO-57
### 7.0 TECHNOLOGICAL CHARACTERSTICS OF THE DEVICE COMAPARED TO PREDICATE DEVICE.
| Measured Parameters of Latex<br>Examination gloves (Powder free)<br>manufactured by Brightway Gloves<br>Pvt.Ltd., | | | ASTM D3578<br>Requirement for<br>Latex Examination<br>glove (Powder free) |
|-------------------------------------------------------------------------------------------------------------------|------|------------|---------------------------------------------------------------------------|
| Characteristics | SIZE | Value | |
| 1. Length | EX-S | 235-240 mm | 220 mm minimum |
| | S | 235-240 mm | 220 mm minimum |
| | M | 235-240 mm | 230 mm minimum |
| | L | 235-240 mm | 230mm minimum |
| 2. Width | EX S | 70MM | 70 +/- 6 mm |
| | S | 82 mm | 80 +/- 6 mm |
| | M | 93 mm | 95 +/- 6 mm |
| | L | 107 mm | 111+/- 6mm |
| 3. Thickness | EX S | 0.10mm | 0.08 mm minimum |
| | S | 0.10mm | 0.08 mm minimum |
| | M | 0.10mm | 0.08 mm minimum |
| | L | 0.10mm | 0.08 mm minimum |
# PHYSICAL PROPERTIES
| | BEFORE AGEING | | AFTER AGEING | |
|-----------------------|---------------------------|--------------------------|------------------------------|--------------------------|
| CHARACTERISTICS | Brightway<br>Gloves Value | ASTD 3578<br>REQUIREMENT | Brightway<br>Gloves<br>Value | ASTD 3578<br>Requirement |
| Tensile Strength | 20 - 22 mpa | 14 mpa min | 18 - 20 mpa | 14 mpa min |
| Elongation at break % | 750 - 800% | 700% min | 700-800% | 500% min |
Image /page/1/Picture/5 description: The image is a circular stamp with the words "BRIGHTWAY GLOVES PVT. LTD." written around the border of the circle. In the center of the circle, the word "NAGERCOIL" is written in bold letters. A five-pointed star is located at the bottom of the circle.
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### PAGE NO-58
# PERFORMANCE REQUIREMENT
| Characteristics | Related defects | Level followed<br>By | | AQL<br>followed by<br>BGPL | AQL Value as<br>per ASTM<br>D3578. |
|-----------------------|------------------------------------------------|----------------------|-------------------------|----------------------------|------------------------------------|
| | | *BGPL | As per<br>ASTM<br>D3578 | | |
| Freedom from<br>Holes | Holes | S4 | S4 | 1.5 | 4 |
| Dimension | Width , Length<br>Thickness. | S2 | S2 | 4 | 4 |
| Physical<br>Property | Tensile<br>Strength,<br>Elongation at<br>Break | S2 | S2 | 4 | 4 |
## POWDER CONTENT
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# PROTEIN CONTENT:
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# MOISTURE CONTENT:
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#### BIOCOMPATABILITY: 1 :
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*BGPL-Brightway Gloves Pvt.ltd
Image /page/2/Picture/12 description: The image shows a circular stamp with the words "IGHTWAY GLOVES PVT. LTD" around the edge. In the center of the stamp, the word "HAGERCOIL" is written in a smaller font. The stamp appears to be slightly faded or worn, giving it a vintage or official look.
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#### 8.0 Performance Data:
The performance test data of the Latex Examination Glove powder free manufactured by M/S Brightway Gloves Pvt.Lltd. is given below.
| Measured Parameters of Latex<br>Examination gloves (Powder free)<br>manufactured by Brightway Gloves<br>Pvt.Ltd., | | |
|-------------------------------------------------------------------------------------------------------------------|------|------------|
| Characteristics | SIZE | Value |
| 1. Length | EX-S | 235-240 mm |
| | S | 235-240 mm |
| | M | 235-240 mm |
| | L | 235-240 mm |
| 2. Width | EX S | 70MM |
| | S | 82 mm |
| | M | 93 mm |
| | L | 107 mm |
| 3. Thickness | EX S | 0.10mm |
| | S | 0.10mm |
| | M | 0.10mm |
| | L | 0.10mm |
#### PHYSICAL PROPERTIES
| CHARACTERISTICS | Before Ageing | After<br>Ageing |
|-----------------------|---------------|-----------------|
| Tensile Strength | 20-22 mpa | 18-20 mpa |
| Elongation at break % | 750-850% | 700-800% |
#### INSPECTION LEVEL OF AQL:
| Characteristics | Related defects | Level | AQL |
|-----------------------|------------------------------------------------|-------|-----|
| Freedom from<br>Holes | Holes | S4 | 1.5 |
| Dimension | Width , Length<br>Thickness. | S2 | 4 |
| Physical<br>Property | Tensile<br>Strength,<br>Elongation at<br>Break | S2 | 4 |
GLOVE 2 1 NAGERCALI
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#### POWDER CONTENT: 1 +/- 1 mg per glove
PROTEIN CONTENT: 80 +/- 20 ppm
#### MOISTURE CONTENT: .0.8% max
### BIOCO MPATABILITY: Biologically Compatible.
NA 9. Clinical Data 0
### 7. CONCLUSION OF PERFORMANCE TEST DATA:
The Latex Examination gloves Powder free manufactured by M/S Brightway Gloves Pvt.Ltd.
- Meet or exceed the ASTM D3578 a
- Meet FDA Pin hole Requirement. -
- Meet labelling claim as shown by the data in 6 -
#### 8. ANY OTHER INFORMATION:
Any other information required by FDA regarding product safety and effectiveness will be provided on request.
Image /page/4/Picture/13 description: The image shows a circular stamp with the text "LIGHTWAY GLOVES PVT. LTD." around the outer edge of the circle. In the center of the circle, the text "NAGERCOIL" is printed in a bold, sans-serif font. The stamp appears to be slightly smudged, giving it a worn or used appearance.
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### DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/5/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.
#### Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 0 2002
Mr. N. Paramasivan Managing Director Brightway Gloves PVT. LTD. Pioneer Manikandan Building Vadasery, Nagar Coil, Tamil Nadu, INDIA
Re: K014279
Trade/Device Name: Latex Examination Gloves (Powder Free) Regulation Number: 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LYY Dated: December 27, 2001 Received: December 27, 2001
#### Dear Mr. Paramasivan:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 – Mr. Paramasivan
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
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Page
510(k) NUMBER (IF KNOWN): K014279 LATEX EXAMINATION GLOVES (POWDER FREE) DEVICE NAME : INDICATIONS FOR USE:
EXAMINATION GLOVES POWDER FREE IS A POWDER FREE LATEX DISPOSABLE DEVICE MADE OF NATURAL RUBBER LATEX INTENDED FOR MEDICAL PURPOSE THAT IS WORN ON THE EXAMINERS HAND ob eximali contrail contrainer time between batten and EXAMINER.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter-Use (Optional Format 1-2-96
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Dev 510(k) Number _
