VINYL PATIENT EXAMINATION GLOVE, POWDER-FREE

K971415 · Shanghai Foremost Plastic Industrial Co., Ltd. · LYZ · May 23, 1997 · General Hospital

Device Facts

• Record ID: K971415
• Device Name: VINYL PATIENT EXAMINATION GLOVE, POWDER-FREE
• Applicant: Shanghai Foremost Plastic Industrial Co., Ltd.
• Product Code: LYZ · General Hospital
• Decision Date: May 23, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1
• Attributes: 3rd-Party Reviewed

Intended Use

A 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.

Device Story

Vinyl patient examination glove; powder-free; disposable. Worn on examiner's hand or finger; acts as physical barrier to prevent contamination between patient and examiner. Used in clinical settings. Device conforms to ASTM D5250-92 standards for dimensions and physical properties; undergoes FDA water leak testing to ensure barrier integrity. Benefits patient and clinician by reducing risk of cross-contamination.

Clinical Evidence

Modified Draize Test performed on human subjects; results indicated no clinically significant irritation and no evidence of induced allergic contact dermatitis.

Technological Characteristics

Vinyl material; powder-free. Dimensions and physical properties (tensile strength, elongation) conform to ASTM D5250-92. Barrier integrity verified via FDA 1000 ml water leak test. Class I medical device.

Indications for Use

Indicated for use by medical examiners to prevent cross-contamination between patient and examiner during medical procedures.

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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# SHANGHAI FOREMOST PLASTIC INDUSTRIAL CO., LTD.

Yan Li River Bridge East, Che Xing Highway, Che Dun Town, Songjiang County, Shanghai 201611, PRC TEL: [phone] FAX: [phone]

K971615
**510 (k) SUMMARY**
MAY 23 1997 Page 1 of 2

## Date of summary prepared: March 25, 1997

3 11 11 11 11 11 1586

- l. Applicant:
Shanghai Foremost Plastic Industrial Co., Ltd. Yan Li River Bridge East Che Xing Highway, Che Dun Town Songjiang County, Shanghai 201611 People's Republic of China Tel:#: [phone], Fax#: [phone]

- 2. Contact Person:
Dr. Tiang S. Chang 1016 Seward Avenue Westfield, N. J. 07090 Fax#: [phone] e-mail: tschang(@earthlink.net Tel#: [phone]

### Name of Device 3.

Vinyl Patient Examination gloves, Powder-free

#### Device Description: 4.

Classified by FDA's General and Plastic Surgery Device Panel as Class I, 21 CFR 880.6250, Vinyl Patient Examination Glove, Powder-free, 80L YZ, conform to all requirements of ASTM Standard D5250-92 and FDA water leak test.

- 5. Intended Use
The applicant device is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.

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# SHANGHAI FOREMOST PLASTIC INDUSTRIAL CO., LTD.

# Yan Li River Bridge East, Che Xing Highway, Che Dun Town, Songjiang County, Shanghai 201611, PRC TEL: [phone] FAX: [phone]

- 510 (k) summary continue.
page 2 of 2.

Inspection Level of S-4

ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘ

- Comparison to Predicate Device 6.
# Non-Clinical Performance data

Applicant devices comply with ASTM Standard D-5250-92 and FDA 1000 ml water leak test for pin-holes.

| Test | ASTM D5250-92 | Applicant Device |
|-------------------------|---------------|--------------------|
| Length (mm) | | |
| Size S | Min. 230 mm | 240 ± 5 mm |
| M | Min. 230 mm | 240 ± 5 mm |
| L | Min. 230 mm | 240 ± 5 mm |
| XL | Min. 230 mm | 240 ± 5 mm |
| Width (mm) | | |
| Size S | 85 ± 5 mm | 87 ± 3 mm |
| M | 95 ± 5 mm | 98 ± 3 mm |
| L | 105 ± 5 mm | 106 ± 3 mm |
| XL | 115 ± 5 mm | 114 ± 3 mm |
| Thickness (mm) | | |
| Finger | Min. 0.05 mm | Min. 0.08 mm |
| Palm | Min. 0.08 mm | Min. 0.11 mm |
| Physical Properties | | |
| Before Aging | | |
| Tensile Strength (MPa) | Min. 9 MPa | Min. 10 MPa |
| Ultimate Elongation (%) | Min. 300% | Min. 300% |
| After Aging | | |
| Tensile Strength (MPa) | Min. 9 MPa | Min. 9.5 MPa |
| Ultimate Elongation (%) | Min. 300% | Min. 300% |
| FDA Water Leak Test | | Meets AOL 4.0 with |

### Clinical Performance Data

The results of Modified Draize Test suggest the applicant device did not induce clinically significant irritation nor show any evidence of induced allergic contact dermatitis in human subjects.

### 7. Conclusions

The applicant devices conform fully to ASTM D5250-92 and applicable 21 CFR requirements, and meets FDA 1000 ml Water Leak Test.

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・一

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.

## MAY 2 3 1997

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Shanghai Foremost Plastic Industrial Co, Ltd. C/O Mr. Robert Mosenkis President . . . . . . CITECH 5200 Butler Pike Plymouth Meetling, Pennsylvania 19462-1298

Re : K971415 Vinyl Patient Examination Glove, Powder-Free Trade Name: Regulatory Class: I Product Code: LYZ Dated: April 16, 1997 Received: April 17, 1997

Dear Mr. Mosenkis:

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 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 (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. ਜੋ 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 regulation 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

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Page 2 - Mr. Mosenkis

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.

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

Timot Directo Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radioloqical Health

Enclosure

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Altachment I b

1 of 1 Page

510(k) Number (if known): KG71415

Device Name: Patient Examination_Glove, Powder-Free

Indications For Use:

A 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.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Qhin S. Lin

(Division Sign. Division of Det. Control. and General Hospital Devices 510(k) Number

scription Use Jr 21 CFR 801.109) OR

Over-The-Counter Use X

(Optional Formal 1-2-96)