(267 days)
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 :
Chemotherapy Drug Permeation (Breakthrough Detection Time) in Minutes.
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.
Non Sterile. Powder-Free. Nitrile Examination for Use with Chemotherapy Drugs
Here's an analysis of the provided information regarding the acceptance criteria and the study that proves the device meets them:
Device: Royal Guard Nitrile Examination Glove Tested For Use with Chemotherapy Drugs (Blue, Green, White)
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Standard (Acceptance Criteria) | Device Performance (Reported) |
|---|---|---|
| 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) | Primary Skin Irritation in Rabbits | Meets |
| Biocompatibility (Sensitization) | Guinea Pig Sensitization | Meets |
| Chemotherapy Drug Permeation | ASTM D 6978-05 (Specific Breakthrough Time) | See Breakthrough Time in Section 14 |
Chemotherapy Drug Permeation (Breakthrough Detection Time in Minutes) - Section 14 Data:
| Chemotherapy Drug | Blue Glove Performance | Green Glove Performance | White Glove Performance |
|---|---|---|---|
| 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 |
Note on Chemotherapy Drug Permeation: The "acceptance criteria" for chemotherapy drug permeation are the results themselves, as they are being reported to define the specific capabilities of the gloves. The underlying standard for testing is ASTM D 6978-05. The document includes warnings for specific glove colors regarding certain chemotherapy drugs due to lower breakthrough times.
2. Sample Size and Data Provenance (for test set/performance data)
The document does not explicitly state the sample sizes used for each of the performance tests (Dimensions, Physical Properties, Freedom from Holes, Powder-Free Residue, Biocompatibility, and Chemotherapy Drug Permeation). It only says the testing "meets" the respective ASTM standards or criteria.
For Chemotherapy Drug Permeation, the data provenance is implicitly from laboratory testing conducted by the manufacturer or a contracted lab to meet ASTM D 6978-05. The country of origin for the manufacturing and potentially the testing is Thailand, as the submitter's address is in Thailand. Given the nature of these tests, they are inherently prospective for the device being submitted.
3. Number of Experts and Qualifications for Ground Truth
This information is not applicable as the device is a medical glove, and its performance is evaluated against engineering and chemical standards, not by expert interpretation of clinical data or images. Ground truth is established through objective physical and chemical testing.
4. Adjudication Method (for test set)
Not applicable. Adjudication methods (like 2+1, 3+1) are used for resolving disagreements among multiple experts in image interpretation or clinical diagnosis. This device's performance is determined by objective laboratory measurements against defined standards.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This type of study evaluates the improvement in human reader performance (e.g., radiologists interpreting images) with or without AI assistance. The device is a physical medical glove, not an AI-powered diagnostic tool.
6. Standalone (Algorithm Only) Performance Study
Not applicable. The device is a physical glove, not an algorithm. Therefore, "standalone" performance in the context of an algorithm does not apply. The performance data presented (e.g., breakthrough times, physical properties) are inherent to the device itself.
7. Type of Ground Truth Used
The ground truth used for evaluating this device's performance is based on objective measurements and adherence to established industry standards.
- Engineering/Physical Standards: For dimensions, physical properties, freedom from holes, and powder-free residue, the ground truth is defined by the specifications and test methods outlined in ASTM D 6319-00a (2005) and ASTM D 6124-06.
- Biocompatibility Standards: For primary skin irritation and guinea pig sensitization, the ground truth is established by the results of standard animal testing protocols designed to assess biological response.
- Chemical Permeation Standard: For chemotherapy drug permeation, the ground truth is the experimentally determined breakthrough time as measured according to ASTM D 6978-05.
8. Sample Size for the Training Set
Not applicable. This device is not an AI/ML algorithm that requires a "training set." Its performance is based on physical and chemical properties.
9. How the Ground Truth for the Training Set was Established
Not applicable. As there is no training set for this type of device, this question is not relevant.
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SHUN THAI RUBBER GLOVES INDUSTRY PUBLIC COMPANY LIMI
9 Moo-4 Kached, Muang Rayong, RAYONG 21100, THAILAÑD Tel. (+66) 3863 4072-3, (+66) 3863 4816 FAX : (+66) 3863 4001,(+66)3863 4480
E-mail address: shunthai@shunthais.com
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: | (+66)38 634 4072 |
| 4. | Fax: | (+66)38 634 4001 |
| 5. | Contact Person: | Mr. Hew Seng Yeap ( Marketing Director) |
| 6. | Official Correspondent: | Mr. Kok-Kee Hon |
| 7. | Address: | 6324 Meetinghouse WayAlexandria. 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 withChemotherapy 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 theexaminer's hand to prevent contamination between examiner and patient and toprotect examiner from the following Chemotherapy drugs tested to ASTM D 6978with 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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ﻟﻲ ﺍﻟﻤﺮﺍﺟﻊ
SHUN THAI
SHUN THAI RUBBER GLOVES INDUSTRY PUBLIC COMPANY LỊM
9 Moo-4 Kached, Muang Rayong, RAYONG 21100, THAILAÑD
Tel. (+66) 3863 4072-3, (+66) 3863 4816 FAX : (+66) 3863 4001,(+66)3863 4480
E-mail address: shunthai@shunthais.com
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.
-
- 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 DrugPermation | ASTM D 6978-05 | See Breakthrough Time InSection 14 |
-
- 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 (800) 638-2041 or (301) 796-7100 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. (+66) 3863 4072-3, (+66) 3863 4816 FAX : (+66) 3863 4001,(+66)3863 4480
E-mail address: shunthai@shunthais.com 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 Hospitalnfection Control, Dental Devices | ||
| 20510(k) Number: | 1092617 |
§ 880.6250 Non-powdered patient examination glove.
(a)
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.(b)
Classification. Class I (general controls). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.