LATEX EXAMINATION GLOVE (POWDERED)

K014280 · Brightway Gloves Pvt. , Ltd. · LYY · Mar 20, 2002 · General Hospital

Device Facts

• Record ID: K014280
• Device Name: LATEX EXAMINATION GLOVE (POWDERED)
• 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

Indications for Use

Latex Examination glove (powdered) is a disposable device made of Natural Latex intended for medical purpose that is worn on the examiners hand or finger to prevent contamination between patient and examiner and is powdered with a donning powder absorbable USP corn starch.

Device Story

Disposable natural latex examination glove; powdered with USP corn starch for donning. Used by healthcare examiners to prevent cross-contamination between patient and examiner. Device is worn on the hand or finger during clinical examinations. Provides a physical barrier; benefits patient and examiner by reducing risk of contamination.

Clinical Evidence

Bench testing only. Device performance evaluated against ASTM D3578 requirements for dimensions, physical properties (tensile strength, elongation at break), and freedom from holes. Biocompatibility confirmed. No clinical data provided.

Technological Characteristics

Natural latex examination glove; powdered with absorbable USP corn starch. Dimensions and physical properties comply with ASTM D3578. Biocompatible. Single-use, disposable.

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.

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 (powdered) (80LYY)

Submission Summary (Full Text)

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PAGE NO: 50

### 1.0. 510K SUMMARY as required by: 807.92(c)

| 2.0 APPLICANT | K014280 MAR 2 0 2002 |
|----------------------|----------------------------------------------------------------------------|
| NAME | M/s. BRIGHTWAY GLOVES PVT.LTD. |
| ADDRESS | PIONEER MANIKANDAN BUILDINGS VADASERY, NAGERCOIL, TAMILNADU, INDIA-629001. |
| PH.NO. | 91-4652-276046, 276291 |
| FAX NO | 91-4652-274271. |
| CONTACT PERSON | MR. N. PARAMASIVAN MANAGING DIRECTOR. |
| 3. DEVICE TRADE NAME | : NIL |
| COMMON NAME | : Patient Examination Glove (powdered) |

- 4. Legally marketed device to which the company claiming equivalence: Class I Patient Examination Gloves (powdered) 80LYY that meets all the requirements of ASTM D3578 .
### 5. DESCRIPTION OF THE DEVICE:

Class I Patient Examination Gloves (powdered) 80L that meets all 'the requirements of ASTM D3578.

6. Intended use of the Device:

Latex Examination glove (powdered) is a disposable device made of Natural Latex intended for medical purpose that is worn on the examiners hand or finger to prevent contamination between patient and examiner and is powdered with a donning powder absorbable USP corn starch.

Image /page/0/Picture/8 description: The image is a circular seal with the words 'BRIGHTWAY GLOVES PVT. LTD.' around the outer edge. Inside the circle is the word 'NAGERCOIL' in bold, block letters. A five-pointed star is at the bottom of the seal.

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### 7.0 TECHNOLOGICAL CHARACTERSTICS OF THE DEVICE COMAPARED TO PREDICATE DEVICE.

| Measured Parameters of<br>Examination gloves (powdered)<br>manufactured by Brightway Gloves | | | ASTM D3578<br>Requirement for<br>Examination glove<br>(powdered) |
|---------------------------------------------------------------------------------------------|------|------------|------------------------------------------------------------------|
| 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 | BGPL VALUE * | ASTD 3578<br>REQUIREMENT | BGPL VALUE | ASTD 3578<br>Requirement |
| Tensile Strength | 20 - 22 mpa | 14 mpa min | 18 – 20 mpa | 14 mpa min |
| Elongation at break % | 800 - 850% | 700% min | 750-800% | 500% min |

## BGPL -- BRIGHTWAY GLOVES PVT.LTD.

and the control of the state

Image /page/1/Picture/6 description: The image shows a circular stamp with the words "BRIGHTWAY GLOVES PVT. LTD." around the outer edge. In the center of the stamp, the word "NAGERCOIL" is printed. A five-pointed star is located at the bottom of the stamp.

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### 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

| .<br>DAT TITT | THE THE THE FEATURE FOR |
|---------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
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## PROTEIN CONTENT:

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## MOISTURE CONTENT:

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## BIOCOMPATIBLITY:

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#### 8.0 Performance Data:

The performance test data of the Latex Examination Glove (powdered) manufactured by Brightway Gloves Pvt.Ltd given below.

| Measured Parameters of<br>Examination gloves (powdered)<br>manufactured by Brightway Gloves Pvt.<br>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

| DICITICA | | |
|-----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------|
| A 914 | 11.02 | |
| Elongation at break % | MARKER FREE LE LE LE LEBERT -------------------------------------------------------------------------------------------------------------------------------------------------- | 2000/ |

## INSPECTION LEVEL AND 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 |

Image /page/3/Picture/8 description: The image is a circular stamp with the words "BRIGHTWAY GLOVES PVT. LTD." written around the border of the circle. Inside 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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POWDER CONTENT: 120 +/- 20 mg per glove

PROTEIN CONTENT: 80 +/- 20 ppm

MOISTURE CONTENT: .0.8% max

BIOCOMPATIBILITY: Biologically Compatible.

9. Clinical Data : NA

#### CONCLUSION OF PERFORMANCE TEST DATA: 10.

The Examination gloves (powdered) manufactured by M/S Brightway Gloves Pvt.Ltd,

. . Meet or exceed the ASTM D3578

- Meet FDA Pin hole Requirement. -
- Meet labelling claim as shown by the data in 6 -

### 11. ANY OTHER INFORMATION:

Any other information required by FDA regarding product safety and effectiveness will be provided on request.

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a stylized human figure. The logo is black and white.

#### 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: K014280

Trade/Device Name: Latex Examination Gloves (Powdered) 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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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

Enclosure

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DUPLICATE

K 014280/A'

Page ol

510(k) NUMBER (IF KNOWN0014280 (

DEVICE NAME LATEX-EXANTHATION GLOVES (FOMDERED)

INDICATIONS FOR USE:

EXAMINATION GLOVE (POWDERED) IS A DISPOSABLE DEVICE LATEX MEDICAL PURPOSE THAT IS NATURAL LATEX INTENDED FOR MADE OF WORN ON THE EXAMINERS HAND OR FINGER TO PREVENT CONTAMINATION AND TO PAWDEREA WITH ARSANAAAFF BETWEEN PATIENT AND EXAMINER DUSTING POWDER USP CORN STARCH.

(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)

ાર

Over-The-Counter-Use (Optional Format 1-2-96)

Chiu S. Lin

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devic 510(k) Number _