PATIENT EXAMINATION GLOVES

K102838 · Thai Hua Holding Co., Ltd. · LYY · Feb 3, 2011 · General Hospital

Device Facts

• Record ID: K102838
• Device Name: PATIENT EXAMINATION GLOVES
• Applicant: Thai Hua Holding Co., Ltd.
• Product Code: LYY · General Hospital
• Decision Date: Feb 3, 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 powdered latex examination gloves; worn by healthcare examiners on hands; function as physical barrier to prevent cross-contamination between patient and examiner; non-sterile; intended for medical use.

Clinical Evidence

No clinical data. Substantial equivalence supported by non-clinical bench testing including dimensions, physical properties, freedom from holes (ASTM D 5151-06), residual powder (ASTM 6124-06), protein content (ASTM D 5712-99), and biocompatibility (primary skin irritation and guinea pig sensitization).

Technological Characteristics

Material: Latex. Standards: ASTM D 3578-05 (dimensions, physical properties), ASTM D 5151-06 (freedom from holes), ASTM 6124-06 (residual powder), ASTM D 5712-99 (protein content). Biocompatibility: CPSC Title 16 Part 1500:41, ISO 10993-10: 2002(E). Non-sterile.

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 (K891300)

Submission Summary (Full Text)

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# THAI HUA HOLDING CO. LTD

K102838

## 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS As required by §807.92(c) 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Powdered Latex Examination Gloves

FEB - 3 2011

| 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 |

- Powdered Latex Examination Gloves. (CFR 880.6250) Common Name: 4.
- 5. Classification: Class 1
- The Powdered Latex Examination Gloves is substantially equivalent to legally market Predicate Device: 6. K891300 Latex Patient Examination Gloves, class I (21CFR 880.6250), product code LYY that meet all the requirements of ASTM D 3578-05 Standard Specification for Rubber Examination Gloves.
- Device Description; Powdered Latex Examination Gloves. non-sterile. 7.

#### Intended Use of the Device: 8.

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

#### Technological Characteristics of Device: 9.

I comboogied. Characteristics or Gloves characteristics are summarized below as compared to ASTM standard requirements and to predicate devices:

| CHARACTERICS | STANDARDS | DEVICE PERFORMANCE |
|---------------------|-------------------------------------------------------------------------------|--------------------------|
| Dimensions | ASTM D 3578-05 | Meets |
| Physical Properties | ASTM D 3578-05 | Meets |
| Freedom from Holes | ASTM D 3578-05<br>ASTM D 5151-06 | Meets<br>AQL 1.5 |
| Residual Powder | ASTM 6124-06 | Less than 10 mg per dm² |
| Protein Content | ASTM D 5712-99 | Less that 200 µg per dm² |
| Biocompatibility | Primary Skin Irritation in Rabbits<br>CPSC Title 16, Chapter II, Part 1500:41 | Passes |
| Biocompatibility | Guinea Pig Sensitizations<br>ISO 10993-10: 2002(E) | Passes |

Are summarized above 10. Performance Data:

- Not required Clinical Data: 11.
- 12. Conclusion:

The Powdered Latex Examination Gloves base on the nonclinical tests The Fordered Later as effective and performs at least as safely and effectively as the legally market predicate device identified or legally marketed Latex Patient Examination Gloves, Class I (21CFR 880.6250), product code LYY. December 4th, 2010

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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a stylized eagle with three lines representing its wings, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular fashion around the eagle. The logo is in black and white.

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 - 3 201

Re: K102838

Trade/Device Name: Powdered Latex Examination Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LYY Dated: January 24, 2011 Received: January 26, 2011

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 /ucm115809.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,

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 Canter for Devices and Radiological Health

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## INDICATION FOR USE

| Applicant: | THAI HUA HOLDING CO., LTD |
|--------------|------------------------------------|
| | 510 (K) Number: |
| Device Name: | Powdered Latex Examination 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______________________________________________________________________________________________________________________________________________________________ (Part 21CFR 801.109) (PLEASE DO NOT INRITE BELOW THIS LINE)

X AND/OR Over the-Counter Use

(21 CFR 801 Subpart C)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Elizabeth F. Clamie-Will

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

510(k) Number: K102838