VINYL PATIENT EXAMINATION GLOVES POWDERED

K973902 · Everrise Glove Products Co., Ltd. · LYZ · Nov 18, 1997 · General Hospital

Device Facts

• Record ID: K973902
• Device Name: VINYL PATIENT EXAMINATION GLOVES POWDERED
• 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

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.

Device Story

Vinyl patient examination glove; disposable; powdered with absorbable dusting starch (USP). Worn by healthcare examiners on hands/fingers to provide barrier protection against contamination between patient and examiner. Device is non-sterile. Performance verified via ASTM D5250-92 standards and FDA 1000ml water leak test for pin-holes. Used in clinical settings to protect both patient and provider.

Clinical Evidence

Clinical performance evaluated via Modified Draize Test. Results indicated the device did not induce clinically significant irritation or allergic contact dermatitis in human subjects.

Technological Characteristics

Vinyl material; powdered with absorbable dusting starch (USP). Dimensions and physical properties (tensile strength, elongation) conform to ASTM D5250-92. Barrier integrity verified by FDA 1000ml water leak test (AQL 4.0).

Indications for Use

Indicated for use as a disposable medical glove worn on the examiner's hand or finger 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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# EVERRISE GLOVE PRODUCTS CO., LTD

No. 47, Huan Kung Road, Wang Haun Li, Yung Kang City Tainan Hsien, Taiwan, R.O.C. NDV 1 8 1997 TEL: [phone] FAX: [phone]

## 510(K) Summary

Page 1 of 3

K973902

Date of summary prepared : October 9th, 1997

#### Applicant 1

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 1

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]

#### Device Name 1

Vinyl Patient Examination Gloves, Powdered

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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 를

- (A) Classified by FDA 's General and Plastic Surgery Device Panel as Class I, 21CFR 880.6250
- (B) Vinyl Patient Examination Glove, 80LYZ, Powdered with an absorbable dusting starch powder, USP, Class III.
- (C) conform to all requirements of ASTM Standard D5250-92 and FDA 1000ml water leak test.

#### Application 방

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 를

Non-Clinical Perfomance data

| 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 | | |
| Before Aging | | |
| Tensile Strength (Mpa) | Min. 9Mpa | Min. 10Mpa |
| Ultimate Elongation (%) | Min. 300% | Min. 300% |

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

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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 행

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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 8 1997

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

Re : K973902 Trade Name: Vinyl Patient Examination Gloves Powdered Regulatory Class: I Product Code: LYZ Dated: October 9, 1997 Received: October 14, 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 reqistration, listing of devices, good 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 requlations affecting your device can be found in the Code of Federal Regulations, 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 Requlation (QS) for Medical 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 Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531

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Page 2 - Mr. Chang

through 542 of the Act for devices under the Electronic enroagle Siz of Control provisions, or other Federal laws or requlations.

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 yitro 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,

Tim A. Whetstone

Timoth 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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Altachment I b

of I l Page

| 510(k) Number (if known): | KG13902 |
|---------------------------|---------|
|---------------------------|---------|

_cvice Name:_Patient Examination Glove, Powdered

### 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)

George J. Mueller, Jr. (Kim S. Tan, Ph.D

(Divisio Division and Gene 510(k) Num

Prescription Use (Per 21 CFR 801.109)

.

OR

Over-The-Counter Use

(Optional Format 1-2-96)