VINYL PATIENT EXAMINATION GLOVES POWDER-FREE

K973998 · Everrise Glove Products Co., Ltd. · LYZ · Nov 18, 1997 · General Hospital

Device Facts

• Record ID: K973998
• Device Name: VINYL PATIENT EXAMINATION GLOVES POWDER-FREE
• Applicant: Everrise Glove Products Co., Ltd.
• Product Code: LYZ · General Hospital
• Decision Date: Nov 18, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

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

Disposable vinyl patient examination glove; worn on examiner's hand/finger; acts as physical barrier to prevent cross-contamination between patient and examiner. Used in clinical settings. Device provides protection during examinations; prevents transmission of contaminants. Performance verified via water leak testing and physical property analysis.

Clinical Evidence

Modified Draize Test performed to assess skin irritation and sensitization potential. Results indicated no clinically significant irritation or evidence of induced allergic contact dermatitis in human subjects.

Technological Characteristics

Vinyl material; powder-free. Dimensions and physical properties conform to ASTM D5250-92. Meets FDA 1000ml water leak test (AQL 4.0, Inspection Level S-4).

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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# EVERRISE GLOVE PRODUCTS CO., LTD

No. 47, Huan Kung Road, Wang Haun Li, Yung Kang City Tainan Hsien, Taiwan, R.O.C. Nr. 18 1997 TEL: [phone] FAX: [phone]

## 510(K) Summary

K973998

## Page 1 of 3

Date of summary prepared : October 9th, 1997

#### Applicant 트

Everrise Glove Products Co., Ltd. No. 47, Huan Kung Road Wang Haun Li Yung Kang City Tainan Hsien Taiwan, R.O.C. Tel : [phone] Fax : [phone]

#### Contact Person 그

Mr. Jason Chang No. 47, Huan Kung Road Wang Haun Li Yung Kang City Tainan Hsien Taiwan, R.O.C. Tel : [phone] Fax : [phone] E-Mail : [e-mail]

#### 배 Device Name

Vinyl Patient Examination Gloves, Powder Free

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# EVERRISE GLOVE PRODUCTS CO., LTD

No. 47, Huan Kung Road, Wang Haun Li, Yung Kang City Tainan Hsien, Taiwan, R.O.C. TEL: [phone] FAX: [phone]

## Page 2 of 3

#### Device Description 트

- (A) Classified by FDA 's General and Plastic Surgery Device Panel as Class I, 21CFR 880.6250
- (B) Viryl Patient Examination Glove, Power Free, 80LYZ
- (C) conform to all requirements of ASTM Standard D5250-92 and FDA water leak test.

#### Application 를

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

#### Comparison to Predicate Device 이

Non-Clinical Perfomance data

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

| Test | ASTM D5250-92 | Applicant Device |
|-------------------------------------|---------------|------------------|
| Length (mm) | | |
| Size S | Min. 230mm | 240±5mm |
| M | Min. 230mm | 240±5mm |
| L | Min. 230mm | 240±5mm |
| XL | Min. 230mm | 240±5mm |
| Width (mm) | | |
| Size S | 85±5mm | 87±3mm |
| M | 95±5mm | 97±3mm |
| L | 105±5mm | 107±3mm |
| XL | 115±5mm | 114±3mm |
| Thickness (mm) | | |
| Finger | Min. 0.05mm | Min. 0.08mm |
| Palm | Min. 0.08mm | Min. 0.11mm |
| Physical Properties<br>Before Aging | | |
| Tensile Strength (Mpa) | Min. 9Mpa | Min. 10Mpa |
| Ultimate Elongation (%) | Min. 300% | Min. 300% |

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## EVERRISE GLOVE PRODUCTS CO., LTD No. 47, Huan Kung Road, Wang Haun Li, Yung Kang City Tainan Hsien, Taiwan, R.O.C. TEL: [phone] FAX: [phone]

Page 3 of 3

| After Aging | | |
|-------------------------|-----------|-------------------------------------------------|
| Tensile Strength (Mpa) | Min. 9Mpa | Min. 9.5Mpa |
| Ultimate Elongation (%) | Min. 300% | Min. 300% |
| FDA Water Leak Test | | Meets AQL 4.0 with a<br>Inspection Level of S-4 |

### 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.

#### Conclusion i

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

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Jason Chang ·General Manager Everrise Glove Products Company, Ltd. No. 47, Huan Kung Road Wanq Haun Li, Yung Kang City Tainan Hsien, Taiwan, R.O.C.

K973998 Re: Vinyl Patient Examination Gloves Powder-Free Trade Name: Requlatory Class: I Product Code: LYZ Dated: October 9, 1997 Received: October 21, 1997

Dear Mr. Chang:

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. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical would Devices: General requlation (21 CFR Part 820) and that, through periodic (QS) 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 Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531

Image /page/3/Picture/8 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 & HI" on the left side and "AN SERVICES USA" on the right side. In the center of the seal is an abstract image of an eagle.

NOV 1 8 1997

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Page 2 - Mr. Chang

through 542 of the Act for devices under the Electronic cinfough 542 or the not is on other Federal laws or requlations.

This letter will allow you to begin marketing your device as first ibed in your 510 (k) premarket notification. The FDA acperiod in your tial equivalence of your device to a legally rinding of subblancial equivality in a classification for your markees produce, 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on compreator as (advertising of your device, please contact che promocron and lawce at [phone]. Also, please note ene organs or entitled, "Misbranding by reference to the regaracion cherorou, prematice noorroour 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,

Tim W. Ulatowski

Timet my A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radioloqical Health

Enclosure

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Allachment I b

K972998 510(k) Number (if known):

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)

.: ienzo S. Macheller, Chus, Zim, PhD

(Division Sign-O tion Control, Division of Dental, Infoc and General Hospital D 5 (J/k) Number

scription Use . cr 21 CFR 801.109) OR

Over-The-Counter Use

(Optional Formal 1-2-96)