BALDUR BRAND VINYL POWDER-FREE EXAMINATION GLOVES

K022091 · Tangshan Zhonghong Pulin Group Co., Ltd. · LYZ · Dec 30, 2002 · General Hospital

Device Facts

• Record ID: K022091
• Device Name: BALDUR BRAND VINYL POWDER-FREE EXAMINATION GLOVES
• Applicant: Tangshan Zhonghong Pulin Group Co., Ltd.
• Product Code: LYZ · General Hospital
• Decision Date: Dec 30, 2002
• 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 purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Device Story

Vinyl patient examination glove; disposable; worn on examiner's hand or finger. Primary function is barrier protection to prevent contamination between patient and examiner. Used in clinical settings. Device is a passive physical barrier.

Clinical Evidence

Bench testing only. Device meets ASTM D 5250-00 requirements for dimensions, physical properties (tensile strength), and biocompatibility. Accelerated aging testing performed per ASTM D573.

Technological Characteristics

Material: Vinyl (polymer coated). Standards: ASTM D 5250-00 (dimensions, physical requirements), ASTM D573 (accelerated aging). Tensile strength: 9.0 MPa (min). Dimensions: S, M, L, XL sizes with specific width/length tolerances. Non-sterile, powder-free.

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.

Predicate Devices

• Class I vinyl patient examination gloves 80LYZ

Submission Summary (Full Text)

{0}------------------------------------------------

# TANGSHAN ZHONGHONG PULIN FOOD PRODUCTS CO.,LTD.

LUANNAN,TANGSIIAN CITY,HEBEI PROVINCE,CHINA Tel: [phone]

Fax: [phone]

022091

## 510 (k) SUMMARY

1) Submitter's name and address:

Baldur Systems Corporation

DEC 3 0 2002

33235 Transit Avenue

Union City,CA 94587

Telephone and Fax numbers of submitter:

Tel:[phone]

Fax:[phone]

David Hu,Ph.d.,president Contact person:

Date summary prepared: April 30,2002

- 2) Common name: Exam gloves
Classification name: Patient examination glove

- 3) Legally marketed device:
Class I vinyl patient examination gloves

80LYZ,powder-frce,that mects all the requirements

of ASTM D 5250-00.

4) Description of the device:

Class I vinyl patient examination gloves 80LYZ,powder-free,that meets all the requirements of ASTM D 5250-00.

{1}------------------------------------------------

## TANGSHAN ZHONGHONG PULIN FOOD PRODUCTS CO.,LTD.

LUANNAN,TANGSHAN CITY,HEBEI PROVINCE,CHINA

Tel: [phone] Fax: [phone]

5) Intended use of device:

A patient examination glove is a disposable

Device,intended for medical purpose that

is worn on the examiner's hand or finger to

prevent contamination between patient and

cxaminer.

6a)Technological characteristics compared to ASTM standard

D 5250 - 00:

Dimension and tolerance (S-2,AQL 4.0)

| | S | M | L | XL | Tolerance |
|--------|-----|-----|-----|-----|-----------------------|
| Width | 85 | 95 | 105 | 115 | $\pm$ 5 (ASTM D 5250) |
| | 85 | 95 | 105 | 115 | $\pm$ 3 (ZHONGHONG) |
| Length | 230 | 230 | 230 | 230 | min (ASTM D 5250) |
| | 230 | 230 | 230 | 230 | min (ZHONGHONG) |

Biocompatability data arc conducted on the polymer coated vinyl gloves.

Physical requirements

Before and after accelerated aging 70±2 ℃ C for 72±2 hours,according to D573.(Inspection level S-2,AQL 4.0)

Tonsile strength (Mpa,min): 9.0

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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 stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular pattern around the symbol. The caduceus is depicted in black, and the text is also in black. The logo is simple and recognizable, representing the department's mission to protect the health of all Americans.

Public Health Service

DEC 3 0 2002

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Tangshan Zhonghong Pulin Food Products Company Limited C/O Dr. David Hu HTI Trading Group 33235 Transit Avenue Union City, California 94587

Re: K022091

Trade/Device Name: Vinyl Examination Gloves, Powder-Free Regulation Number: 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LYZ Dated: November 8, 2002 Received: December 9, 2002

Dear Dr. Hu:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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### Page 2 - Dr. Hu

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 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), 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Timothy A. Ulatowski

Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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Page **_ of**

ко22091 510(k) Number (if known):

Vinyl Exam Gloves, Powder-free Device Name:_

Indications For Use

A Vinyl patient examination glove is a disposable device intended for medical purposes 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 NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Chin S. Lim

Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental De

510(k) Number: K022091

Prescription Use_ (Per 21 CFR 801 109) OR

Over-The-Counter Use __

(Oplional Formal 1