SHANGHAI GLOVMAX ENTERPRISE CO, LTD., POWDER-FREE VINYL PATIENT EXAMINATION GLOVES

K993880 · Shanghai Glovmax Enterprise Co.,Ltd · LYZ · Jan 12, 2000 · General Hospital

Device Facts

• Record ID: K993880
• Device Name: SHANGHAI GLOVMAX ENTERPRISE CO, LTD., POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
• Applicant: Shanghai Glovmax Enterprise Co.,Ltd
• Product Code: LYZ · General Hospital
• Decision Date: Jan 12, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

A patient examination gloves is a disposable device intended for medical purposes that 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

Disposable vinyl patient examination glove; worn by healthcare personnel on hands/fingers; acts as physical barrier to prevent contamination between examiner and patient body, fluids, waste, or environment. Device is non-sterile, powder-free, and intended for single use in clinical or medical settings.

Clinical Evidence

No clinical data. Bench testing only: physical and dimension testing (ASTM D-5250-92, AQL 4.0), FDA 1000 ml water fill test (AQL 2.5), and biocompatibility testing (primary skin irritation and sensitization).

Technological Characteristics

Material: Vinyl. Standard: ASTM D-5250-92. Form factor: Disposable examination glove. Powder-free (verified via USP Iodine Test). Testing: Physical/dimensional, water fill (pinhole), biocompatibility. Non-sterile.

Indications for Use

Indicated for use as a disposable medical device worn on the examiner's hand or finger to prevent cross-contamination between the patient and the 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 Huamao Gloves Co., Ltd. (K984460)

Submission Summary (Full Text)

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# SHANGHAI GLOVMAX ENTERPRISE CO., LTD.

Song Jiang Industrial Zone, Che Dun Branch Zone, Rong Chang Rd., #2, Shanghai, China C/O: Room B, 11F, No. 201, Nanking E. Rd., Sec.3, Taipei, Taiwan, R.O.C.

JAN 1 2 2000

TEL: [phone] 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:

## 1.Submitter's Identification:

Mr. Mao-Sheng Lee SHANGHAI GLOVMAX ENTERPRISE CO., LTD. Song Jiang Industrial Zone, Che Dun Branch Zone, Rong Chang Rd., #2, Shanghai, China

Date Summary Prepared: Nov. 5, 1999

# 2.Name of the Device:

SHANGHAI GLOVMAX ENTERPRISE CO., LTD. Powder-free Vinyl Examination Gloves

### 3. Predicate Device Information:

Shanghai Huamao Gloves Co., Ltd. #K984460

### 4.Device Description:

Classified by FDA's General and Plastic Surgery Device Panel as Class I, 21 CFR 880.6250, Powder-free 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 patient examination gloves is a disposable device intended for medical purposes that 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 GLOVMAX ENTERPRISE CO., LTD.

Song Jiang Industrial Zone, Che Dun Branch Zone, Rong Chang Rd., #2, Shanghai, China C/O: Room B, 11F, No. 201, Nanking E. Rd., Sec.3, Taipei, Taiwan, R.O.C.

> TEL: [phone] FAX: [phone]

### 6.Comparison to Predicate devices:

SHANGHAI GLOVMAX ENTERPRISE CO., LTD. Powder-free Vinyl Patient Examination Gloves, is substantially equivalent in safety and effectiveness to the Shanghai Huamao Gloves Co., Ltd. Powder-free vinyl patient examination Gloves.

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

The standards used for SHANGHAI GLOVMAX ENTERPRISE 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.

A USP Iodine Test for Starch at finished inspection is conducted to insure that our gloves meet our "powder-free" claim. We adhere to all USP Iodine Test methodology and testing "powder-residue by weight" and are contracting with a laboratory to conduct particulate testing for added assurance. Final release testing consists of a light transmission test using a spectrophotometer.

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

Not Applicable - There is not hypoallergenic claim.

#### 9.Conclusions:

SHANGHAI GLOVMAX ENTERPRISE 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.

#### ATTACHMENT B. PAGE 2 OF 2

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Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal features the department's logo, which consists of a stylized caduceus symbol with three intertwined snakes and a staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the logo.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 2 2000

Mr. Mao-Shenq Lee, President Shanghai Glovmax Enterprise Co., Ltd. Room B, 11th Floor, No. 201
Nanking E. Road, Sec. 3 Taipei, Taiwan, R.O.C.

Re : K993880 Shanghai Glovmax Enterprise Co., Ltd. Trade Name: Powder-Free Vinyl Patient Examination Gloves Requlatory Class: I Product Code: LYZ Dated: November 5, 1999 Received: November 15, 1999

Dear Mr. Lee:

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. ದ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (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

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Page 2 - Mr. Lee

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 requlation 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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#### ATTACHMENT A

Page __ 1__ of _ 1

510(k) number (if known): 943880

Shanghai Glovmax Enterprise Co., Ltd. Device name: Powder-free Vinyl 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)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

OR

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

Qun S. Lim

ental. Infection Control, 510/k) Numb