ROYAL GUARD

K092617 · Shun Thai Rubber Gloves Industry Public Co., Ltd. · LZA · May 20, 2010 · General Hospital

Device Facts

• Record ID: K092617
• Device Name: ROYAL GUARD
• Applicant: Shun Thai Rubber Gloves Industry Public Co., Ltd.
• Product Code: LZA · General Hospital
• Decision Date: May 20, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Indications for Use

This is a disposable device intended for medical application that is worn on the examiner's hand to prevent contamination between examiner and patient and to protect examiner from the following Chemotherapy drugs tested to ASTM D 6978 with the indicated Breakthrough Detection Times :

Device Story

Disposable nitrile examination gloves (blue, green, white); worn by healthcare examiners; prevents cross-contamination between patient and examiner; provides barrier protection against specific chemotherapy drugs; tested per ASTM D 6978 for breakthrough detection times; performance varies by color/drug combination; specific warnings provided for Carmustine and Thio-Tepa; used in clinical settings.

Clinical Evidence

Bench testing only. Device performance evaluated against ASTM D 6319-00a (dimensions, physical properties, freedom from holes), ASTM D 6124-06 (powder-free residue), and ASTM D 6978-05 (chemotherapy drug permeation). Biocompatibility confirmed via primary skin irritation and guinea pig sensitization studies.

Technological Characteristics

Nitrile rubber material; powder-free; non-sterile; available in blue, green, and white. Complies with ASTM D 6319, ASTM D 6124, and ASTM D 6978. Biocompatible per skin irritation and sensitization testing.

Indications for Use

Indicated for use as a disposable patient examination glove worn by examiners to prevent cross-contamination between patient and examiner and to provide protection against specific chemotherapy drugs.

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

• Powder-Free Nitrile Examination Glove (K051333)

Submission Summary (Full Text)

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K092617

SHUN THAI RUBBER GLOVES INDUSTRY PUBLIC COMPANY LIMI

9 Moo-4 Kached, Muang Rayong, RAYONG 21100, THAILAÑD Tel. [phone] FAX : [phone]

E-mail address: [e-mail]

Highly Intend To Reply Your Satisfaction .......

# 510(k) Summary As Required by 21 Section 807.92 (c)

MAY 2 0 2010

'ﮨﮯ''

| 1. | Submitter Name: | Shun Thai Rubber Gloves Industry Public Company Limited |
|-----|-----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2. | Address: | 9. Moo 4. Kached Muang. Rayong. Thailand 21100 |
| 3. | Phone: | ([phone] |
| 4. | Fax: | ([phone] |
| 5. | Contact Person: | Mr. Hew Seng Yeap ( Marketing Director) |
| 6. | Official Correspondent: | Mr. Kok-Kee Hon |
| 7. | Address: | 6324 Meetinghouse Way<br>Alexandria. VA 22312. USA |
| 8. | Phone: | 703-941-7656 |
| 9. | Fax: | 703-941-2551 |
| 10. | Device Trade or Proprietary Name: | Royal Guard Nitrile Examination Glove Tested For Use with<br>Chemotherapy Drugs |
| 11. | Device Common or Usual Name: | Examination Glove |
| 12. | Device Classification Name: | Nitrile Patient Examination Glove (Powder-Free) |
| 13. | Description of the Device: | Non Sterile. Powder-Free. Nitrile Examination for Use with Chemotherapy Drugs |
| 14. | Intended Use of the Device: | This is a disposable device intended for medical application that is worn on the<br>examiner's hand to prevent contamination between examiner and patient and to<br>protect examiner from the following Chemotherapy drugs tested to ASTM D 6978<br>with the indicated Breakthrough Detection Times : |

### Chemotherapy Drug Permeation (Breakthrough Detection Time) in Minutes.

| Nitrile Powder Free Examination Glove | Blue | Green | White |
|---------------------------------------|--------|-------|-------|
| *Carmustine (BCNU) | 40.00 | 17.00 | 9.00 |
| Cyclophosphamide (Cytoxan) | > 240 | > 240 | > 240 |
| Doxorubicin HCl (Adriamycin) | >240 | > 240 | > 240 |
| Etoposide (Toposar) | >240 | > 240 | > 240 |
| Fluorouracil | >240 | > 240 | > 240 |
| Paclitaxel (Taxol) | >240 | > 240 | > 240 |
| *Thio-Tepa | 177.00 | 63.00 | 48.00 |
| Cisplatin | >240 | > 240 | > 240 |
| Dacarbazine (DTIC) | >240 | > 240 | > 240 |

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K092617

ﻟﻲ ﺍﻟﻤﺮﺍﺟﻊ


SHUN THAI

SHUN THAI RUBBER GLOVES INDUSTRY PUBLIC COMPANY LỊM

9 Moo-4 Kached, Muang Rayong, RAYONG 21100, THAILAÑD

Tel. [phone] FAX : [phone]

E-mail address: [e-mail]

Highly Intend To Reply Your Satisfaction .......

### Nitrile Powder Free Examination Glove (Blue)

* CAUTION: Testing showed average breakthrough time of 40.00minutes with Carmustine.

## Nitrile Powder Free Examination Glove (Green)

* WARNING: DO NOT USE WITH CARMUTINE.

### Nitrile Powder Free Examination Glove (White)

* CAUTION: Testing showed average breakthrough time of 48.00minutes with Thio-Tepa.

* WARNING: DO NOT USE WITH CARMUTINE.

- 15. Summary of The Technological Characteristics of the Device: The following technological characteristics of the Device compared to ASTM or Equivalent Standards are summarized below

| CHARACTERISTICS | STANDARDS | DEVICE PREFORMANCE |
|--------------------------------|------------------------------------|----------------------------------------|
| Dimensions | ASTM D 6319-00a (2005) | Meets |
| Physical Properties | ASTM D 6319-00a (2005) | Meets |
| Freedom from Holes | ASTM D 6319-00a (2005) | Meets |
| Powder-Free Residue | ASTM D 6124-06 | Meets |
| Biocompatibility | Primary Skin Irritation in Rabbits | Meets |
| Biocompatibility | Guinea Pig Sensitization | Meets |
| Chemotherapy Drug<br>Permation | ASTM D 6978-05 | See Breakthrough Time In<br>Section 14 |

- 16. Substantial Equivalents Based on Assessment of Non-Clinical Performance Data: The performance test data of the non-clinical tests that support a determination of substantial equivalence is the same as mentioned above in Section 15.
### 17. Conclusion

It can be concluded that the Royal Guard Powder-Free Nitrile Examination Glove Tested For Use With Chemotherapy Drugs will perform to the glove performance standards referenced in Section 15 and meets the ASTM standards and FDA requirements. This device is therefore substantially equivalent to currently marketed devices. It is sale and effective as the predicate device 510K 051333 Powder-Free Nitrile Examination Glove.

I 8. Date Summary Prepared: July 10. 2009

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

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

Shun Thai Rubber Gloves Industry Public Company Limited C/O Mr. Kok-Kee Hon 6324 Meeting House Way Alexandria, Virginia 22312-1718

MAY 20 2010

Re: K092617

Trade/Device Name: Royal Guard Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA, LZC Dated: May 11, 2010 Received: May 14, 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. Kok-Kee 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/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/ReportalProblem/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 vours.

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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Image /page/4/Picture/0 description: The image shows a logo with two stylized hands forming the shape of the letter 'S'. The hands are stacked on top of each other, with the fingers of each hand pointing towards the center of the 'S' shape. Below the logo, the words 'SHUN THAI' are printed in a simple, sans-serif font. The logo is black and white and appears to be a company or brand identifier.

SHUN THAI RUBBER GLOVES INDUSTRY PUBLIC COMPANY LIMITED

9 Moo-4 Kached, Muang Rayong, RAYONG 21100, THAILAND

Tel. [phone] FAX : [phone]

E-mail address: [e-mail] Highly Intend To Reply Your Satisfaction ......

# INDICATION FOR USE

Applicant: Shun Thai Rubber Gloves Industry Public Company Limited

510 (K) Number: K 092617

Device Name: Nittile, Blue, White and Green Examination Gloves, Powder Free and Tested For

Use with Chemotherapy . Drugs

Indications for Use:

This glove is disposable and intended purpose that is worn on the examiner 's hand to prevent contamination between patient and examiner, gloves use for protection against chemotherapy drugs as below.

### Chemotherapy Drug Permeation (Breakthrough Detection Time) in Minutes.

| Nitrile Powder Free Examination Glove | Blue | Green | White |
|---------------------------------------|--------|-------|-------|
| *Carmustine (BCNU) | 40.00 | 17.00 | 9.00 |
| Cyclophosphamide (Cytoxan) | > 240 | > 240 | > 240 |
| Doxorubicin HCI (Adriamycin) | >240 | > 240 | > 240 |
| Etoposide (Toposar) | >240 | > 240 | > 240 |
| Fluorouracil | >240 | > 240 | > 240 |
| Paclitaxel (Taxol) | >240 | > 240 | > 240 |
| *Thio-Tepa | 177.00 | 63.00 | 48.00 |
| Cisplatin | >240 | > 240 | > 240 |
| Dacarbazine (DTIC) | >240 | > 240 | > 240 |

Nitrile Powder Frec Examination Clove(Blue)

* CAUTION: Testing showed average breakthrough time of 40.00minutes with Carmustine.

Nitrile Powder Free Examination Glove(Green)

* warning: do not use with Carmutine.

Nitrile Powder Free Examination Glove(White)

*CAUTION: Testing showed average breakthrough time of 48.00minutes with Thio-Tepa.

* WARNING: DO NOT USE WITH CARMUTINE.

| Prescription Use | | AND/OR Over the-Counter Use | |
|--------------------------------------------------------|----------------------|----------------------------------------------------------------------------------|---|
| (Part 21CFR 801 Subpart D) | | (21 CFR 801 Subpart C) | X |
| (PLEASE DO NOT INRITE BELOW THIS LINE) | | | |
| | (Division Sign-Off) | | |
| Concurrence of CDRH, Office of Device Evaluation (ODE) | | ) vision of Anesthesiology, General Hospital<br>nfection Control, Dental Devices | |
| | 20<br>510(k) Number: | 1092617 | |