BALDUR BRAND VINYL POWDERED EXAMINATION GLOVES, SUN FLOWER GLOVES CO., LTD

K022336 · Tangshan Zhonghong Pulin Group Co., Ltd. · LYZ · Oct 11, 2002 · General Hospital

Device Facts

• Record ID: K022336
• Device Name: BALDUR BRAND VINYL POWDERED EXAMINATION GLOVES, SUN FLOWER GLOVES CO., LTD
• Applicant: Tangshan Zhonghong Pulin Group Co., Ltd.
• Product Code: LYZ · General Hospital
• Decision Date: Oct 11, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

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.

Device Story

Disposable vinyl patient examination glove; worn on examiner's hand or finger; intended to prevent contamination between patient and examiner. Device is used in clinical settings; operated by healthcare professionals. Provides physical barrier protection. Manufactured using PVC resin, DOP, TXIB, epoxidized soybean oil, and Ca/Zn carboxylate stabilizer.

Clinical Evidence

Bench testing only. Device meets ASTM D5250-00 requirements for physical properties and FDA 1000ml water leak test for pinholes.

Technological Characteristics

Material: PVC resin, DOP, TXIB, epoxidized soybean oil, Ca/Zn carboxylate stabilizer. Standard: ASTM D5250-00. Form factor: Powdered vinyl examination glove. Principle: Physical barrier. Sterilization: Not specified.

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,TANGSHAN CITY,HEBEI PROVINCE,CHINA

Tcl: 86-315-4168379 Fax: [phone]

KO 22336

# 510 (k) SUMMARY

OCT 1 1 2002

1) Submitter's name and address:

Baldur Systems Corporation

33235 Transit Avenue

Union City,CA 94587

Telephone and Fax numbers of submitter:

Tel:[phone]

Fax:[phone]

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

l)ate 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,powdered,that meets all the requirements

of ASTM D 5250-00.

- 4) Description of the device:
Class I vinyl patient examination gloves 80LYZ,powdered,that meets all the requirements of ASTM D 5250-00.

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

#### TANGSHAN ZHONGHONG PULIN FOOD PRODUCTS CO.,LTD. LUANNAN,TANGSHAN CITY,HEBEI PROVINCE,CHINA Tcl: 86-315-4168379 Fax: [phone]

### EQUIVALENCE CLAIM

We claim that our gloves are equivalent to class I vinyl examination glove, product code 80LYZ,powdered,that meet all the requirements of ASTM standard D5250-00. For details please see bclow:

l ) Chemical data

Name of chemicals:

PVC resin

DOP(di-octyl-phthalate)

TXIB(2,2,4 trimthyl ,1,3 pentanediol,diisobutylate)

Epoxidized Soyabean Oil

Ca/Zn carboxylate stabilizer

2)Size specification and physical properties.

Please refer to attached sheet.(SPECIFICATION OF POWDERED

VINYL EXAMINATION GLOVFS,APRIL 30,2002)

3) Pin Holc

3.1 Test method: use FDA 1000ml water leak test.

3.2 Sampling procedure and acceptance quality level.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

# OCT 11 2002

Re: K022336

Trade/Device Name: Vinyl Examination Gloves, Powdered Regulation Number: 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: 80 LYZ Dated: September 11,2002 Received: October 1, 2002

Dear Mr. 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 – Mr. 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 and additionally 21 CFR Part 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" (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.qov/cdrh/dsma/dsmamain.html

Sincerely yours.

Patina Curritiffor

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

Enclosure

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Page **_ of _**

| 510(k) Number (if known): | K022336 |
|---------------------------|-----------------------------|
| Device Name: | Vinyl Exam Gloves, Powdered |

Indications For Use:

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: 上一篇:

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and the control of the count

100000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000

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 II NEEDED)

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| Prescription Use | OR | Over-The-Counter Use X |
|---------------------------------------------------------------------------------|---------|------------------------|
| (Per 21 CFR 801.109) | | (Optional Format 1-2 |
| | | |
| (Division Sign-Off) | | |
| Division of Anesthesiology, General Hospital, Infection Control, Dental Devices | | |
| 510(k) Number: | K022336 | |