PATIENT EXAMINATION GLOVES

K102846 · Thai Hua Holding Co., Ltd. · LZA · Mar 17, 2011 · General Hospital

Device Facts

• Record ID: K102846
• Device Name: PATIENT EXAMINATION GLOVES
• Applicant: Thai Hua Holding Co., Ltd.
• Product Code: LZA · General Hospital
• Decision Date: Mar 17, 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 nitrile examination gloves; worn by healthcare examiners to provide barrier protection; prevents cross-contamination between patient and examiner; non-sterile; blue color; intended for medical use; manual application by clinician.

Clinical Evidence

No clinical data; bench testing only. Device performance verified against ASTM D 6319-00a(2005) for dimensions and physical properties, ASTM D 5151-06 for freedom from holes (AQL 1.5), and ASTM 6124-06 for powder-free residual (< 2 mg/glove). Biocompatibility confirmed via primary skin irritation (16 CFR 1500.41) and ISO 10993-10 sensitization testing.

Technological Characteristics

Material: Nitrile. Form factor: Powder-free examination glove. Standards: ASTM D 6319-00a(2005), ASTM D 5151-06, ASTM 6124-06. Biocompatibility: ISO 10993-10. 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

• Nitrile Patient Examination Gloves (K051333)

Submission Summary (Full Text)

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THAI HUA HOLDING COMPANY LIMITED

| | 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS<br>As required by §807.92(c) |
|--------------------------------|--------------------------------------------------------------------------------|
| | 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS |
| | Powder Free Nitrile Examination Gloves (Blue) |
| 1. Applicant: | THAI HUA HOLDING CO., LTD. |
| | 238/1 Ratchadapisek 18, Huaykwang |
| | Bangkok 10320 Thailand |
| | Tel: [phone] |
| | Fax: [phone] |
| 2. Contact Person: | Mr. Reyong Kittipol |
| | Managing Director |
| | Tel: [phone] |
| | Fax: [phone] |
| | Or |
| | Kok-Kee Hon |
| | Technical Advisor & Official Correspondent |
| | 6324 Meetinghouse Way |
| | Alexandria, VA 22312 USA |
| | Tel: [phone] |
| | Fax: [phone] |
| 3. Device Name: | Patient Examination Gloves |
| 4. Common Name: | Powder Free Nitrile Examination Gloves (Blue) (CFR 880.6250) |
| 5. Classification: | Class 1 |
| 6. Predicate Device: | The Powder Free Nitrile Examination Gloves is substantially equivalent to |
| | legally market K051333 Nitrile Patient Examination Gloves, class I (21CFR |
| | 880.6250), product code LZA that meet all the requirements of ASTM D 6319-05 |
| | Standard Specification for Nitrile Examination Gloves for Medical Application. |
| 7. Device Description: | Powder Free Nitrile Examination Gloves (Blue), 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 contamination between patient and examiner. |

## 9. Technological Characteristics of Device:

The Powder Free Nitrile Examination Gloves characteristics are summarized below as compared to ASTM requirements and to predicate devices:

| CHARACTERICS | STANDARDS | DEVICE PERFORMANCE |
|----------------------------------------------------------------|-----------------------------------------------------------------------------------------|--------------------------|
| Dimensions | ASTM D 6319-00a(2005) | Meets |
| Physical Properties | ASTM D 6319-00a(2005) | Meets |
| Freedom from Holes | ASTM D 6319-00a(2005)<br>ASTM D 5151-06 | Meets<br>Meets AQL 1.5 |
| Powder Free Residual | ASTM 6124-06 | Less than 2 mg per glove |
| Biocompatibility<br>Primary Skin Irritation<br>Test in Rabbits | Consumer Product Safety Commission, Title<br>16, Chapter II, Part 1500.41& 1500:3(C)(4) | Passes |
| Biocompatibility<br>Guinea Pig<br>Sensitization Test | ISO 10993-10: 2002(E), Dermal Sensitiztion<br>Assay-Closed Patch Test | Passes |

10. Performance Data Arc summarized above

11. Clinical Data: Not required

12. Conclusion:

"

.

The Powder Free Nitrile Examination Gloves (Blue) base on the nonclinical tests performed, the Powder-Free Nitrile Examination Gloves is as safe, as effective and performs at least as safely and effectively as the legally marketed predicate device identified or legally marketed Nitrile Patient Examination Gloves, Class I (21CFR 880.6250). product code LZA. December 4th, 2010

13. Prepared Date:

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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized image of an eagle.

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

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

MAR 1 7 2011

Re: K102846

Trade/Device Name: Powder-Free Nitrile Examination Gloves (Blue) Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: 1 Product Code: LZA Dated: February 7, 2011 Received: February 11, 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

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/AboutlFDA/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/Reporta Problem/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,
Jans J. Koso
for

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

## Enclosure

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## INDICATION FOR USE

| Applicant: | THAI HUA HOLDING CO., LTD |
|-----------------|--------------------------------------------------------------------|
| 510 (K) Number: | .................................................................. |
| Device Name: | Powder-Free Nitrile Examination Gloves (Blue) |

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__

X AND/OR Over the-Counter Use

(Part 21CFR 801.109)

(PLEASE DO NOT WRITE BELOW THIS LINE)

(21 CFR 801 Subpart C)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Elijabeth T. Clavie-Willem

Division of Anesthesialogy, General Hospital ton Control, Dental Devices Intec

510(k) Number: K102846