PRE-POWDER VINYL PATIENT EXAMINATION GLOVES

K984461 · Shanghai Huamao Gloves Co., Ltd. · LYZ · Feb 9, 1999 · General Hospital

Device Facts

• Record ID: K984461
• Device Name: PRE-POWDER VINYL PATIENT EXAMINATION GLOVES
• Applicant: Shanghai Huamao Gloves Co., Ltd.
• Product Code: LYZ · General Hospital
• Decision Date: Feb 9, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

A glove is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient's body, fluids, waste or environment.

Device Story

Pre-powdered vinyl patient examination glove; worn by healthcare personnel to provide barrier protection against contamination from patient body fluids, waste, or environment. Device is disposable; intended for use in clinical or similar settings. Manufactured to meet ASTM D5250-92 standards for physical dimensions and integrity. Barrier function verified via FDA 1000 ml water fill test. Biocompatibility confirmed through primary skin irritation and sensitization testing.

Clinical Evidence

No clinical data. Bench testing only: physical and dimensions testing (ASTM D5250-92, AQL 4.0), FDA 1000 ml water fill test (AQL 2.5), and biocompatibility testing (primary skin irritation and sensitization) showing no adverse reactions.

Technological Characteristics

Vinyl patient examination glove; powdered with absorbable dusting powder (USP). Meets ASTM D5250-92 standards. Barrier integrity verified by 1000 ml water fill test. Biocompatible materials.

Indications for Use

Indicated for use as a disposable medical device 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

• Shanghai Super Gloves Co., Ltd. (K974151)

Submission Summary (Full Text)

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## SHANGHAI HUAMAO GLOVES CO., LTD.

No. 8, New Industrial Area, Zhu Hang Zhen, Jin Shan County, Shanghai, China C/O: Room C, 11F, 201, Nanking E Rd., Sec. 3, Taipei, Taiwan, R.O.C. Tel/Fax: [phone]

#### 510(K) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR § 807.92.

The assigned 510(k) number is : K984461

#### 1.Submitter's Identification:

Mr. Hsieh, I-shih SHANGHAI HUAMAO GLOVES CO., LTD. No. 8, New Industrial Area, Zhu Hang Zhen, Jin Shan County, Shanghai, China

Date Summary Prepared: 27 November 1998

#### 2. Name of the Device:

SHANGHAI HUAMAO GLOVES CO., LTD. Pre-powder Vinyl Examination Gloves

#### 3. Predicate Device Information:

Shanghai Super Gloves Co., Ltd. #K974151

#### 4. Device Description:

Classified by FDA's General and Plastic Surgery Device Panel as Class I, 21 CFR 880.6250, Pre-powder Vinyl Patient Examination Glove, 80LYZ, powdered with Absorbable Dusting Powder, USP, Class III and meets all requirements of ASTM Standard D5250-92.

#### 5.Intended Use:

A glove is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient's body, fluids, waste or environment.

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# SHANGHAI HUAMAO GLOVES CO., LTD.

No. 8, New Industrial Area, Zhu Hang Zhen, Jin Shan County, Shanghai, China C/O: Room C, 11F, 201, Nanking E Rd., Sec. 3, Taipei, Taiwan, R.O.C. Tel/Fax: [phone]

#### 6. Comparison to Predicate devices:

SHANGHAI HUAMAO GLOVES CO., LTD. Pre-powder Vinyl Patient Examination Gloves, is substantially equivalent in safety and effectiveness to the Shanghai Super Gloves Co., Ltd. Pre-powder vinyl patient examination Gloves.

### 7.Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as follows:

The standards used for SHANGHAI HUAMAO GLOVES CO., LTD. Production are based on ASTM D-5250-92. All testing meets requirements for Physical and Dimensions Testing conducted on gloves, Inspection Level S-2, AQL 4.0.

The FDA 1000 ml. Water Fill Test was also conducted with samplings of AQL 2.5, Inspection Level S-4, meeting these requirements. Primary Skin Irritation and Skin Sensitization (allergic contact dermatitis) testing was conducted with results showing no primary skin irritant or sensitization reactions.

There are no special labeling claims and we do not claim our gloves as hypoallergenic on our labels.

SHANGHAI HUAMAO GLOVES CO., LTD. Operates in compliance with FDA's GMPs.

#### 8. Discussion of Clinical Tests Performed:

Not Applicable - There is no hypoallergenic claim.

#### 9.Conclusions:

SHANGHAI HUAMAO GLOVES CO., LTD. Vinyl Patient Examination Gloves conform fully to ASTM D-5250-92 standards as well as applicable 21 CFR references, and meets pinhole FDA requirements, bio-compatibility requirements and labeling claims as shown by data in Section 7. There are no safety/efficacy issues or new claims from the " substantial equivalence" products cited.

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Image /page/2/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" arranged around the perimeter. Inside the circle is a stylized image of an eagle, represented by three curved lines that suggest the bird's head and wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

9 1999 FEB

Shanghai Huamao Gloves Co. Ltd. C/O Ms. Susan D. Goldstein-Falk Official Correspondent MDI Consultants, Incorporated 55 Northern Boulevard, Suite 200 Great Neck, New York 11021

Re: K984461 Pre-Powder-Free Vinyl Patient Examination Trade Name: Gloves Requlatory Class: I Product Code: LYZ December 14, 1998 Dated: Received: December 16, 1998

Dear Ms. Goldstein-Falk:

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, 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 Regulations, Title 21, Parts 800 to 895. A 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 obligation you might have under sections 531 through 542 of

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Page 2 - Ms. Goldstein-Falk

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 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 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 qeneral 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

Timothy A. Ulatows 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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Exhibit A

Page of

| 510(k) NUMBER (IF KNOWN): | K984461 |
|---------------------------|------------------------------------------------------------------------------|
| DEVICE NAME: | SHANGHAI HUAMAO GLOVES CO., LTD. Pre-Powder Vinyl Patient Examination Gloves |
| 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.)

Concurrent of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) OR

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

Olin S. Lin

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