POWDER FREE LATEX EXAMINATION GLOVES WITH ALOE VERA, NATURAL WATER, SOLUBLE VITAMIN E AND VITAMIN C AND PROTEIN LABELING

K042645 · Qingdao Bestex Rubber & Plastic Products Co., Ltd. · LYY · Nov 26, 2004 · General Hospital

Device Facts

• Record ID: K042645
• Device Name: POWDER FREE LATEX EXAMINATION GLOVES WITH ALOE VERA, NATURAL WATER, SOLUBLE VITAMIN E AND VITAMIN C AND PROTEIN LABELING
• Applicant: Qingdao Bestex Rubber & Plastic Products Co., Ltd.
• Product Code: LYY · General Hospital
• Decision Date: Nov 26, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

The powder free latex examination glove with Aloe Vera, water soluble natural Vitamin E and C and protein labeling claim (50 microgram or less) is a disposable device made of natural rubber latex that may bear a trace amount of glove powder and is intended for medical purposes that are worn on the examiner's hands or fingers to provide a barrier against potentially infectious materials and other contaminants.

Device Story

Disposable natural rubber latex examination glove; coated with Aloe Vera, water-soluble Vitamin E, and Vitamin C. Used by healthcare professionals in clinical settings as a protective barrier against infectious materials and contaminants. Device provides physical barrier protection; does not serve as a chemical barrier. Manufactured to meet ASTM D3578-01 standards for physical properties and dimensions; protein content labeled at ≤50 µg/g to address latex sensitivity concerns. Biocompatibility confirmed via skin irritation and sensitization testing.

Clinical Evidence

No clinical data. Bench testing only: physical properties, dimensions, pinhole rate (AQL 1.5), powder content (ASTM D6124-01), protein levels (ASTM D5712-99), and biocompatibility (primary skin irritation and dermal sensitization in rabbits).

Technological Characteristics

Natural rubber latex; powder-free (<2 mg/glove); protein content ≤50 µg/g. Complies with ASTM D3578-01 (dimensions, physical properties), ASTM D6124-01 (powder), and ASTM D5712-99 (protein). Biocompatible per skin irritation/sensitization testing.

Indications for Use

Indicated for use as a disposable medical glove worn on examiner's hands or fingers to provide a barrier against infectious materials and contaminants. Not intended for use as a chemical barrier.

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.

Submission Summary (Full Text)

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## NOV 2 6 2004

# 510(K) SUMMARY

# 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

POWDER FREE LATEX EXAMINATIN GLOVES WITH ALOE VERA,NATURAL WATER SOLUBLE VITAMIN E AND VITAMIN C AND PROTEIN LABELING CLAIM(50 MICROGRAM OR LESS PER GRAM OF GLOVE)

This summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990, and prepared on Oct. 20, 2004

The assigned 510(K) number is K 042645

#### 1.0 Submitter:

Qingdao Bestex Rubber & Plastic Products Co. Ltd. 14-2 Hangzhou Road, Pingdu., Qingdao, China

## 2.0 Regulatory Affairs Contact:

Name: ZeChuan Shao Phone No.: 408 980 1348 Fax No .: 408 980 1356

#### 3.0 Name of device:

Trade Name: Undetermined Common Name: Examination Glove Classification Name: Patient Examination Glove, Powder Free

#### 4.0 Identification of The Legally Marketed Device:

Class I patient examination gloves, 80LYY, non-sterile, powder free with Aloe Vera, natural water soluble Vitamin E and C, that meets all the requirements of ASTM standard 3578-01 and FDA 21 CFR 800.20.

#### 5.0 Device Description:

Class I powder free latex examination gloves with Aloe Vera, natural water soluble Vitamin E and C and protein labeling claim(50 microgram or less), 80LYY, nonsterile meets all the requirements of ASTM standard D3578-01 and FDA 21 CFR 800.20.

#### 6.0 Intended Use of The Device:

The powder free latex examination glove with Aloe Vera, water soluble natural Vitamin E and C and protein labeling claim (50 microgram or less) is a disposable device made of natural rubber latex that may bear a trace amount of glove powder and is intended for medical purposes that are worn on the examiner's hands or fingers to provide a barrier against potentially infectious materials and other contaminants.

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04-2645

#### 7.0 Summary of the Technological Characteristics of the Device:

The Powder Free Latex Examination Gloves with Aloe Vera, natural water soluble Vitamin E and C and with Protein Content Labeling (50 micrograms or less) are summarized with the following technological characteristics compared to ASTM or equivalent standards:

| Characteristics | Standards | Device Performance |
|---------------------|------------------------------------------------------------|--------------------|
| Dimensions | ASTM D 3578-01 | Meets |
| Physical Properties | ASTM D 3578-01 | Meets |
| Freedom from | ASTM D 3578-01 | Meets |
| Pinholes | FDA 21 CFR 800.20 | Meets |
| Powder Free | ASTM D 6124-01 | <2 mg/glove |
| Protein Level | ASTM D5712-99 | <50 microgram/gram |
| Biocompatibility | Primary Skin Irritation In Rabbits<br>Dermal Sensitization | Passes<br>Passes |

8.0 Substantial Equivalent Based on Assessment of Non-Clinical Performance Data The standards used by Bestex Rubber & Plastic Products Co., Ltd. to determine substantial equivalence are based on ASTM 3578-01 AND FDA 21 CFR 800.20. All testing meets requirements for physical specifications and dimensions conducted on gloves, Inspection level S-2, AQL 4.0, Pinholes at AQL 1.5

Primary Skin Irritation and Skin Sensitization testing were also conducted with results meets all performance and biocompatibility requirements.

- 9.0 Substantial Equivalent Based on Assessment of Clinical Performance Data No new clinical test were conducted under this 510(K)
### 10.0 Other Information Deemed Necessary by FDA:

Not applicable.

## Conclusion

The data presented indicate that the Powder Free Latex Examination Glove with Aloe Vera, natural water soluble Vitamin E and C and with a protein labeling claim (50 microgram or less) meets ASTM standards, meet FDA pinhole requirements , biocompatibility requirements, and labeling claims. Consequently, this device is substantially equivalent to currently marketed devices.

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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 features a stylized eagle with its wings spread, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# NOV 26 2004

Qingdao Bestex Rubber & Plastic Products Company Limited C/O Mr. Zechuan Shao Bestex Protection Supply, Incorporated 2576 Lafayette Street Santa Clara, California 95050

Re: K042645

Trade/Device Name: Powder-Free Latex Examination Glove with Aloe Vera, Natural Water Soluble Vitamin E and C, and Protein Content Labeling (50 Microgram or Less) Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYY Dated: October 20, 2004 Received: November 9, 2004

Dear Mr. Shao:

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 vour 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. Shao

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 (OS) 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]. 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 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,

Chris

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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# Qingdao Bestex Rubber & Plastic Products Co., Ltd.

Add: 14-2, Hangzhou Road, Pingdao, China Tel: [phone] Fax: [phone]

#### 3.0 Indications for Use Statement:

### INDICATIONS FOR USE

Applicant: Oingdao Bestex Rubber & Plastic Products Co., Ltd. 510(k) Number(if known): * Device Name: Powder-free latex examination glove with Aloe Vera, natural water soluble Vitamin E and C, and Protein content labeling(50 microgram or less)

#### Indications For Use:

The Powder-Free Latex Examination Glove with Aloe Vera, natural water soluble Vitamin E and C and with Protein Labeling Claim (50 microgram or less per gram of glove) is a disposable device made of natural rubber latex that may bear a trace amount of glove powder and is intended for medical purpose that is worn on the examiner's hand or finger(s) to provide a barrier against potentially infectious materials and other contaminants.

This device is not intended to be used as a chemical barrier.

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Concurrence of CDRH Office of Device Evaluation (ODE)

Prescription Use Per 21 CFR 801.109 OR

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

Reuts

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

510(k) Number:

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