POWDER FREE VINYL PATIENT EXAMINATION GLOVES, WHITE (NON-COLORED)

K051153 · Hebei Manful Import & Export Co., Ltd. · LYZ · May 18, 2005 · General Hospital

Device Facts

• Record ID: K051153
• Device Name: POWDER FREE VINYL PATIENT EXAMINATION GLOVES, WHITE (NON-COLORED)
• Applicant: Hebei Manful Import & Export Co., Ltd.
• Product Code: LYZ · General Hospital
• Decision Date: May 18, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

powder free vinyl patient examination glove, white(non-colored) 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

Disposable vinyl patient examination glove; worn on examiner's hand or finger; prevents contamination between patient and examiner. Used in clinical settings by healthcare personnel. Device is non-sterile, powder-free, and white. Provides a physical barrier to reduce transmission of pathogens during examinations.

Clinical Evidence

No clinical data. Substantial equivalence is based on non-clinical bench testing, including physical property testing, pinhole leak testing per 21 CFR 800.20, and biocompatibility testing (irritation and sensitization) per ISO 10993-10.

Technological Characteristics

Material: Vinyl. Standards: ASTM D5250-00 (dimensions, physical properties, powder residual), 21 CFR 800.20 (pinholes), ISO 10993-10 (biocompatibility). Form factor: Disposable examination glove. Non-sterile.

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

• FUGUAN (Brand) Powder-Free Vinyl Patient Examination Gloves (K032908)

Submission Summary (Full Text)

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# C 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."

." (applicant leave blank) "The assigned 510(k) number is:

#### Premarket Notification [510(k)] Summary

[(a)(1)]. The summary contains on the first page, preferably on your letterhead paper, the submitter's name, address, phone and fax numbers, name of contact person, and date the summary was prepared :

| Submitter's name : | HEBEI MANFUL IMPORT & EXPORT CO., LTD | |
|--------------------------------|-----------------------------------------------------------------------|--|
| Submitter's address : | NO.58 TONGDA ROAD, JINZHOU CITY, HEBEI<br>PROVINCE, 052260, P.R.CHINA | |
| Phone number : | (86) 311-4338239 | |
| Fax number : | (86) 311-4338239 | |
| Name of contact person: | Ms. Yanchai Zhang | |
| Date the summary was prepared: | 06 April 2005 | |

#### [(a)(2)]. The name of the device, including the trade or proprietary name if applicable, the common or usual name, and the classification name, if known

| Device Name: | Powder Free Vinyl Patient Examination Gloves, white(non-colored) | |
|-------------------------|--------------------------------------------------------------------------------|--|
| Proprietary/Trade name: | Powder Free Vinyl Patient Examination Gloves<br>Other clients private labeling | |
| Common Name: | Patient examination glove | |
| Classification Name: | Patient examination glove | |
| Device Classification: | I | |
| Regulation Number: | 21 CFR 880.6250 | |
| Panel: | General Hospital (80) | |
| Product Code: | LYZ | |

[(a)(3)]. An identification of the legally marketed device to which your firm is claiming substantial equivalence .

Class I* powder free vinyl patient examination gloves , white(non-colored) that mecels all of the requirements of ASTM standard D 5250-00-4.

Predicate device : FUGUAN (Brand) Powder-Free Vinyl Patient Examination Gloves, Shijiazhuang Fuguan Plastic Products Co., Ltd.. K032908 .

### [(a)(4)] A description of the device

Device Description : powder free vinyl patient examination gloves, white(non-colored) that meets all of the requirements of ASTM standard D 5250-0004

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#### [(a)(5)] The summary describes the intended use of the device

Device Intended Use: powder free vinyl patient examination glove, white(non-colored) 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)(6)] A summary of the technological characteristics of new device compared to the predicate device.

The powder free vinyl patient examination gloves, non sterile are summarized with the following technological characteristics compared to ASTM or equivalent standard.

| Characteristics | Standard | Device performance |
|-----------------------|-------------------------------------------|--------------------|
| Dimension | ASTM standard D 5250-00c4 | Meets |
| Physical Properties | ASTM standard D 5250-00c4 | Meets |
| Freedom from pinholes | 21 CFR 800.20 | Meets |
| Powder Residual | ASTM standard D 5250-00c4 | Meets |
| Biocompatability | and D6124-01 | <2mg/glove |
| | Primary Skin Irritation in<br>rabbits | Passes |
| | Dermal sensitization in the<br>guinea pig | Passes |

#### [(b)(1)] A brief discussion of the nonclinical submitted, reference, or relied on in the premarket notification submission for a determination of substantial equivalence .

Powder free vinyl patient examination gloves , white(non-colored) meet requirements per ASTM D5250-004, per ASTM D6124-01, per 21 CFR 800.20 and ISO10993-10.

#### [(b)(2)] A brief discussion of the clinical submitted, reference, or relied on in the premarket notification submission for a determination of substantial equivalence .

Clinical data is not needed for gloves or for most devices cleared by the 510(k) process.

#### [(b)(3)] The conclusions drawn from the nonclinical and clinical tests that demonstrate that the device is as safe,as effective, and performed as well or better than the legally marketed device identified in (a)(3).

It can be concluded that the Powder Free Vinyl Patient Examination Gloves meet the ASTM standard or equivalent standard and FDA requirements for waterleak test on pinhole AQL., meet labeling claims .

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## MAY 1 8 2005

Ms. Yanchai Zhang General Manager Assistant Hebei Manful Import & Export Company Limited No. 58 Tongda Road Jinzhou City, Hebei Province, 052260 P.R. CHINA

Re: K051153

Trade/Device Name: Powder Free Vinyl Patient Examination Gloves, White (Non-Colored) Regulation Number: 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYZ Dated: April 6, 2005 Received: May 4, 2005

Dear Ms. Zhang:

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 Amerade onts, 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 (1 Nr.), it may of bacyco 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 - Ms. Zhang

Please be advised that FDA's issuance of a substantial equivalence determination does not I least that FDA has made a determination that your device complies with other requirements mean that I DA mas made statutes and regulations administered by other Federal agencies. of the riot of ally I outhal the Act's requirements, including, but not limited to: registration 1 ou intist comply with a807); labeling (21 CFR Part 801); good manufacturing practice allu listing (21 OF RT at 807), abolity systems (QS) regulation (21 CFR Part 820); and if requirents as set form in are quality ijon 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) This letter will and A 70 a be objact to and of substantial equivalence of your device to a premarket notification. - The PDF 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), 11 you desire specific acritic at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the may overn built generational and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Chiu Lin, Ph.D.

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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#### INDICATIONS FOR USE

Applicant: HEBEI MANFUL IMPORT & EXPORT CO., LTD

510(k) Number (if known): K051153

Device Name: Powder Free Vinyl Patient Examination Gloves, White(Non-colored)

INDICATIONS FOR USE

Powder free vinyl 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.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

insion Sign-Off) resion of Anesthesiology, General Hospital, Inrection Control, Dental Devices

Number: K 051153

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