PATIENT EXAMINATION GLOES

K102840 · Thai Hua Holding Co., Ltd. · LYY · Feb 18, 2011 · General Hospital

Device Facts

• Record ID: K102840
• Device Name: PATIENT EXAMINATION GLOES
• Applicant: Thai Hua Holding Co., Ltd.
• Product Code: LYY · General Hospital
• Decision Date: Feb 18, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

This glove is disposable and intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.

Device Story

Disposable, non-sterile, powder-free polymer-coated latex examination gloves; worn by healthcare examiners to provide barrier protection against contamination between patient and examiner. Device functions as a physical barrier; manufactured to meet ASTM D 3578-05 standards for physical properties, dimensions, and freedom from holes. Protein content limited to 50µg/dm² or less. Used in clinical or medical settings.

Clinical Evidence

No clinical data. Bench testing only. Performance verified against ASTM D 3578-05 (dimensions, physical properties, freedom from holes), ASTM D 5151-06 (freedom from holes), ASTM D 5712-99 (protein content <50µg/dm²), and ASTM D 6124-06 (powder-free residue <2mg/glove). Biocompatibility established via primary skin irritation (16 CFR 1500.41) and dermal sensitization (ISO 10993-10:2002).

Technological Characteristics

Material: Latex with polymer coating. Standards: ASTM D 3578-05 (dimensions, physical properties), ASTM D 5151-06 (holes), ASTM D 5712-99 (protein), ASTM D 6124-06 (powder residue). Biocompatibility: ISO 10993-10:2002. Non-sterile. Powder-free.

Indications for Use

Indicated for use as a disposable medical glove worn on the examiner's hand 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

• Latex Patient Examination Gloves (Class 1, 21CFR 880.6250, product code LYY)

Submission Summary (Full Text)

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## THAI HUA HOLDING COMPANY K 102840 LIMITED FEB 1 8 2011

| 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS<br>As required by §807.92(c) | |
|------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS | |
| Powder-Free Polymer Coated Latex Examination Gloves | |
| Protein Label Claim (50 micrograms or less of total water extractable protein<br>per square decimeter of gloves) | |
| 1. Applicant | THAI HUA HOLDING CO., LTD.<br>238/1 Ratchadapisek 18, Huaykwang<br>Bangkok 10320 Thailand<br>Tel: [phone]<br>Fax: [phone] |
| 2. Contact Person | Mr. Reyong Kittipol<br>Managing Director<br>Tel: [phone]<br>Fax: [phone]<br>Or<br>Kok-Kee Hon<br>Technical Advisor & Official Correspondent<br>6324 Meetinghouse Way<br>Alexandria, VA 22312 USA<br>Tel: [phone]<br>Fax: [phone] |
| 3. Device Name: | Patient Examination Gloves |
| 4. Common Name: | Powder-Free Polymer Coated Latex Examination Gloves with Protein<br>Labeling (50microgram or less of total water extractable proteins per square decimeter<br>of gloves) |
| 5. Classification: | Class 1 |
| 6. Predicate Device: | This glove is substantially equivalent to legally market Latex Patient Examination<br>Gloves, class 1 (21CFR 880.6250), product code LYY that meet all the requirements of ASTM D 3578-<br>05 Standard Specification for Rubber Examination Gloves. |
| 7. Device Description: | Powder-Free Polymer Coated Latex Examination Gloves with Protein<br>Labeling (50microgram or less of total water extractable proteins per square decimeter<br>of gloves), non-sterile. |
| 8. Intended Use of the Device: | This glove is disposable and intended for medical purpose that is worn on the examiner's hand to prevent<br>contamination between patient and examiner. |
| 9. Technological Characteristics of Device: | The Powder Free-Polymer Coated Latex Examination Gloves characteristics are summarized below as<br>compared to ASTM requirements and to predicate devices: |
| Characteristic | Standard |
| Dimensions | Meets ASTM D 3578-05 |
| Physical Properties | Meets ASTM D 3578-05 |
| Freedom From Holes | Meets ASTM D 3578-05, AQL 1.5<br>Meets ASTM D 5151-06 |
| Protein Content | Meets ASTM D 5712-99, Less than 50µg/dm² |
| Powder Free Residue | Meets ASTM D 6124-06, Less than 2 mg per glove |
| Biocompatibility | Passes Primary Skin Irritation in Rabbits Test as described in Consumer Product Safety<br>Commissions Title 16, Chapter II. Part 1500.41& 1500:3(c)(4)<br>Passes Guinea Pig Sensitization Test as per ISO 10993-10: 2002(E), Dermal Sensitizations<br>Assay- Closed Patch Test |
| 10. Performance Data: | Are summarized above |
| 11. Clinical Data: | Not required |
| 12. Conclusion: | Powder-Free Polymer Coated Latex Examination Gloves with Protein<br>Labeling (50microgram or less of total water extractable proteins per square decimeter of<br>gloves) base on the nonclinical tests performed, this glove is as safe, as effective and performs<br>at least as safely and effectively as the legally marketed predicate device identified or legally<br>marketed Latex Patient Examination Gloves. Class I (21CFR 880.6250), product code LYY. |

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines. The symbol is positioned to the right of the text.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Mr. Kok-Kee Hon Official Correspondent Thai Hua Holding Company, Limited 6324 Meetinghouse way Alexandria, Virginia 22312-1718

FEB 1 8 201

Re: K102840

Trade/Device Name: Provide-Free Polymer Coated Latex Examination Gloves with Protein Labeling (50microgram or Less of Total Water Extractable Proteins Per Square Decimeter of Glove Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LYY Dated: December 22, 2010 Received: December 28, 2010

Dear Mr. Hon:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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. Hon

Enclosure

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801). please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm l 15809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,
Jams J. S
faz

Anthony D. Watson, B.S., M.S., M.B.A. 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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## INDICATION FOR USE

| Applicant: | THAI HUA HOLDING CO., LTD |
|------------|---------------------------|
|------------|---------------------------|

510 (K) Number: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Device Name:

Powder-Free Polymer Coated Latex Examination Gloves with Protein Labeling (50microgram or less of total water extractable proteins per square decimeter of gloves)

Indications for Use:

This glove is disposable and intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.

Prescription Use_

× Over the-Counter Use AND/OR

(Part 21CFR 801.109)

(21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Elizabeth D. Lawrie-Welle

sion of Anesthesiology, General Hospital ion Control. Dental Devices Infe

510(k) Number: K102840