POWDER FREE LATEX EXAMINATION GLOVES

K983998 · Sri Anusham Rubber Industries Pvt., Ltd. · LYY · Jan 21, 1999 · General Hospital

Device Facts

• Record ID: K983998
• Device Name: POWDER FREE LATEX EXAMINATION GLOVES
• Applicant: Sri Anusham Rubber Industries Pvt., Ltd.
• Product Code: LYY · General Hospital
• Decision Date: Jan 21, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Indications for Use

Latex Examination Gloves (Powder Free) referred to as medical device are worn on hand and fingers by the examiner as effective barrier between examiner and patient against exposure to micro organism in blood and other body fluids, waste and equivilent.

Device Story

Powder-free natural rubber latex examination gloves; worn by clinicians on hands/fingers; act as physical barrier against microorganisms, blood, body fluids, and waste; used in clinical settings; protects both patient and examiner from cross-contamination.

Clinical Evidence

Bench testing only. Device meets or exceeds ASTM D 3578-95 specifications for dimensions, physical properties (tensile strength, elongation at break before/after aging), and freedom from holes (AQL 1.5). Biocompatibility confirmed.

Technological Characteristics

Natural rubber latex; powder-free; dimensions (length 220-250mm, thickness 0.08-0.12mm); tensile strength 19-24 MPa; elongation at break 700-850%; meets ASTM D 3578-95 standards.

Indications for Use

Indicated for use by medical examiners on hands/fingers to prevent cross-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.

Submission Summary (Full Text)

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SRI ANUSHAM RUBBER INDUSTRIES TEL: 91 4952 PRIVATE LIMITED 100% EXPORT ORIENTED UNIT

ﮨﮯ ﮐﮧ ﺍﯾﺎ ﮐﺎ ﻟﯿﺎﮞ ﮐﮯ ﻟﯿﮯ ﮐﮧ ﺗﺎ ﮨﮯ ﮐﮧ ﺗﺎ ﮨﮯ ﮐﮧ ﺗﺎ ﮨﮯ ﮐﮧ ﺗﺎ ﮨﮯ ﮐﮧ ﺗﺎ ﮨﮯ ﮐﮧ ﺗﺎ ﮨﮯ ﮐﮧ ﺗﺎ ﮨﮯ ﮐﮧ ﺗﺎ ﮨﮯ ﮐﮧ ﮐﮯ ﺗﺎ ﮨﮯ ﮐﮧ ﺗﺎ ﮨﮯ ﮐﮧ ﺗﺎ ﮨﮯ ﮐﮧ ﺗﺎ ﮨﮯ ﮐﮧ ﺗﺎ ﮨﮯ ﮐﮧ ﮐﮯ ﺗﺎ ﮨﮯ ﮐﮧ ﺗﺎ ﮨﮯ ﮐﮧ ﺗﺎ ﮨ

1. 1. 1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

TLX: 486 209 SIVA IN Tamil Nadu, 5. India.

K9837998

Vadasery, Nagercoil-629001.

## JAN 2 1 1999

| ﺮ | ﺎ | C | | 1 | t | |
|---|---|---|--|---|---|---|
| | | | | Q | | ದ |

#### ពុក ខេ V រ ន E ប

------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

KUMARS

FAX: 91 4652

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SIAK SUMMARY as required by : 807.92(c) 1.0

APPI. ICANT . ે. - W NAME

, SKI ANUSHAM RUBBER INDUSTRIES (P) LTD PIONEER MANIKANDAN BUILDINGS VADASERRY, NAGERCOIL-629001 TAMIL NADU , 5.INDIA

: + 91 4652 23091 િમનભાયદ

: + 41 4652 328/1 t: UX

: MK. N.PARAMASIVAN CONINCT PERSON MANAGING DIRECTDR

DEVICE TRADE NAME : NIL

- : Patient fixamination Gloves-Powder Free COMMON NAME ર -
- I EGALLY MARKETED DEVICE TO WHICH বে এ CLAIMING EQUIVALENCE : COMPANAY

Class 1- Patient Examination Gloven(Powder Free) 90L YY the requirements of meets all that ASTM D 3578 - 95.

Type 1 - Gloves compounded primarily from Natural Rubber Latex.

DESCRIPTION OF THE DEVICE: S .

> Llass 1- Patient Examination Gloves(Powder Free) ROL YY that meets all the requrements ASTM D 3578-95.

INTENDED USE DE THE DEVICE: ત

> Lalex Examination Gloves (Powder Free) referred to as medical device are worn on hand and fingers by the examiner as effective barrier between examiner and patient against exposure to micro organism in blood and other body fluids, waste and equivilent.

PAGE ਉਰ

Page - 52

33091

32871

Page - 53

Pioneer Menikandan Buildings.

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983998

7 . ហ

TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE COMPARED TO PREDICATE DEVICE.

| Measured<br>by<br>SRI<br>TRIES PRIVATE LIMITED | Parameters of Latex<br>Surgeon's Gloves Manufactured<br>ANUSHAM RUBBER INDUS- | ASTM D 3578<br>Requirement for<br>Latex Examination<br>Glove-Powder free | |
|------------------------------------------------|-------------------------------------------------------------------------------|--------------------------------------------------------------------------|---------------------------------------------------------------------------------------------|
| Characteristics Size | Value | Value | Prescribed |
| 1. Length | Ex-S<br>S<br>M<br>L<br>Ex-L | 240-245mm<br>240-245mm<br>240-245mm<br>245-250mm<br>245-245mm | 220 mm minimum<br>220 mm minimum<br>230 mm minimum<br>230 mm minimum<br>230 mm minimum |
| 2. Width | Ex-S<br>S<br>M<br>L<br>Ex-L | 71mm<br>82mm<br>95mm<br>106mm<br>110mm | 70 +/- 6 mm<br>80 +/- 6 mm<br>95 +/- 6 mm<br>111 +/- 6 mm<br>114 +/- 6 mm |
| 3. Thickness | Ex-G<br>S<br>M<br>L<br>Ex-L | 0.11mm<br>0.12mm<br>0.12mm<br>0.10mm<br>0.11mm | 0.08 mm minimum<br>0.08 mm minimum<br>0.08 mm minimum<br>0.08 mm minimum<br>0.08 mm minimum |

PHYSICAL PROPERTICS

| CHARACTERISTICS | BEFORE AGEING | | AFTER AGEING | |
|-------------------------------------------------------|---------------|-------------------------|--------------|-------------------------|
| | *SARI VALUE | ASTM D 3578 REQUIREMENT | SARI VALUE | ASTM D 3578 REQUIREMENT |
| Tensile Strength | 21-24 mpa | 14 mpa min. | 19-22mpa | 14 mpa min |
| Elongation at Break % | 800-850% | 700% min. | 700-800% | 500% min. |
| *SARI - SRI ANUSHAM RUBHER INDUSTRIES PRIVATE LIMITED | | | | |

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#### KUMHAS VA-UA-YC

10

510 k. Submission
Application Page - 55

VU· 16

1877
4. 26

page 3/5

## PERFORMANCE REULITHEMENT

| Characteristics | Related<br>Defects | Level<br>followed<br>By | | AQL<br>followed<br>by SARI | AQL Value<br>as per<br>ASTM D3578 |
|-----------------------|-------------------------------------------------------------------------------|-------------------------|-------------------------|----------------------------|-----------------------------------|
| | | SARI | As per<br>ASTM<br>D3578 | | |
| Freedom trom<br>Holes | Holes | S4 | S4 | 1.5 | 4 |
| Dimensions | Width<br>Length<br>Thickness | S2 | S2 | 4 | 4 |
| Physical<br>Property | Tensile<br>Strength<br>Elongation<br>at Break<br>before &<br>after<br>ageing. | S2 | S2 | 4 | 4 |

### POWDER CONTENT:

| といってーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーー<br>SARI VALUE | ASTN REDUIREMENT |
|----------------------------------------------------------------------------------------------------------------------|------------------|
| ー・アーーンやー・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・<br>80 +1- 20 | 2mq/glove max |
| ーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーー | |

#### PROTEIN CONTENT;

| SARI VALUE | FDA REQUIREMENT |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------|
| イター・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・<br>80+1-20ppm | Value not fixed |

## MO1STURE CONTENT :

| SARI VALUE | tores and commendent commendent ment compression consideration of the<br>FDA REQUIREMENT |
|------------|------------------------------------------------------------------------------------------|
| 0.4%. | Value not fixed<br>ャー・ページーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーー |

## B I D--COMPA FAU IL I T Y

:

| といっても、このことになっても、その他のことになっている。このコーニングのないというということです。 ここで、<br>SARI GLUVE<br>ーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーー | FDA REQUIREMENT |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------|
| Biologically Compatible<br>Look - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - | Biologically Compatible |
| | |

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510 k Submission
Application Page - 56
K983998
Page 4/5

| 8.0 PERFORMANCE DATA | | | |
|------------------------------------------------------------------------------------------------------------------------------------------------|-----------------|------|--------------|
| The Performance Test Data of the Powder Free Examination Gloves manufactured by SRI ANUSHAM RUBBER INDUSTRIES PVT LIMITED is given here-under: | | | |
| Measured Parameters of Latex Examination Gloves (Powder Free) manufactured by SRI ANUSHAM RUBBER INDUSTRIES PRIVATE LIMITED | | | |
| | Characteristics | Size | Value |
| 1. | Length | Ex-S | 240 - 245 mm |
| | | S | 240 - 245 mm |
| | | M | 240 - 245 mm |
| | | L | 245 - 250 mm |
| | | Ex-L | 245 - 250 mm |
| 2. | Width | Ex-S | 71mm |
| | | S | 82mm |
| | | M | 95mm |
| | | L | 106mm |
| | | Ex-L | 110mm |
| 3. | Thickness | Ex-S | 0.11mm |
| | | S | 0.12mm |
| | | M | 0.12mm |
| | | L | 0.10mm |
| | | Ex-L | 0.11mm |

# PHYSICAL PROPERTIES

| CHARACTERISTICS | Before Ageing | After Ageing |
|-----------------------|---------------|--------------|
| Tensile Strength | 21-24 mpa | 19-22 mpa |
| Elongation at break % | 800-850% | 700- 800% |

:39

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510 k Submission
Application Page - 57

08-08-92

K983998

page 5/5

06:19

| INSPECTION LEVEL OF AQL |
|-------------------------|
|-------------------------|

| CHARACTERISTICS | RELATED DEFECTS | LEVEL | AQL |
|---------------------|--------------------------------------------------------------|-------|-----|
| Freedom from holes | Holes | S4 | 1.5 |
| Dimensions | Length, Width & Thickness | S2 | 4 |
| Physical Properties | Tensile Strength<br>Elongation at Break before & after aging | S2 | 4 |

| POWDER CONTENT | 1 +/- 1 mg per glove |
|--------------------|-------------------------|
| PROTEIN CONTENT | 80 +/- 20 ppm |
| MOISTURE CONTENT | 0.4% maximum |
| BI(J-COMPATABILITY | Biologically Compatible |

- ਾ ਹ CLINICAL DATA Not Applicable יי
CONCLUSION OF PERFURMANCE UF TEST DATA

The Powder Free Gloves manufactured by SRI ANUSHAM RUHBER INDUSTRIES PRIVATE LIMITED;

- * Meet or excreed the ASTM DJ578-45 Specifications
- * Meet FDA Pin Hole Requirements
- * Meet Labelling Claim as shown in data under S.No.6

ANY UTHER INFORMATION:

Any other information required by FDA in respect of PRODUCT SAFETY AND EFFECTIVENESS shall be provided on demand.

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Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with three parallel lines above them, resembling a stylized bird or symbol of flight.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 2 1 1999

SRI Anusham Rubber Industries Pvt. Ltd. C/O Mrs. Latha Kumaraswamy P.O. Box 5206 Pleasanton, California 94566 USA

K983998 Re: Powder-Free Latex Examination Gloves Trade Name: Requlatory Class: I Product Code: Lyy Dated: November 4, 1998 Received: November 9, 1998

Dear Mrs. Kumaraswamy:

We have reviewed your Section 510 (k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, qood manufacturing practice, labeling, and prohibitions aqainst misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ರ್ಗ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

{6}------------------------------------------------

#### Page 2 - Mrs. Kumaraswamy

This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/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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510(k) Number (if known): K983998
Device Name: Powder Free Latex Examination Gloves

Indications For Use:

..............................................................................................................................................................................

. . .

3.1 INDICATIONS FOR USE

> AFFLICANT SRI ANUSHAM RUBBER INDUSTRIES PVT.LTD t 510(K) NO 술술 DEVICE NAME POWDER FREE LATEX EXAMINATION GLOVES 1

INDICATIONS FOR USE:

Fowder Free Latex Examination Glove is a device intended for medical use , worn by the Examiner on his hands / fingers to prevent contamination between Patient and Examiner.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Qus-L

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

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use

(Optional Format 1-2-96)