(142 days)
This glove is disposable and intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
Powder-Free Polymer Coated Latex Examination Gloves with Protein Labeling (50microgram or less of total water extractable proteins per square decimeter of gloves), non-sterile.
The provided text describes the acceptance criteria and performance of Powder-Free Polymer Coated Latex Examination Gloves.
1. Table of Acceptance Criteria and Reported Device Performance:
| Characteristic | Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|---|
| Dimensions | Meets ASTM D 3578-05 | Meets ASTM D 3578-05 |
| Physical Properties | Meets ASTM D 3578-05 | Meets ASTM D 3578-05 |
| Freedom From Holes | Meets ASTM D 3578-05, AQL 1.5; Meets ASTM D 5151-06 | Meets ASTM D 3578-05, AQL 1.5; Meets ASTM D 5151-06 |
| Protein Content | Meets ASTM D 5712-99, Less than 50µg/dm² | Less than 50µg/dm² (stated in device name and description) |
| Powder Free Residue | Meets ASTM D 6124-06, Less than 2 mg per glove | Less than 2 mg per glove |
| Biocompatibility | Passes Primary Skin Irritation in Rabbits Test (Consumer Product Safety Commissions Title 16, Chapter II. Part 1500.41& 1500:3(c)(4)) | Passes Primary Skin Irritation in Rabbits Test |
| Biocompatibility | Passes Guinea Pig Sensitization Test (ISO 10993-10: 2002(E), Dermal Sensitizations Assay- Closed Patch Test) | Passes Guinea Pig Sensitization Test |
2. Sample size used for the test set and the data provenance:
The document does not explicitly state the specific sample sizes used for each test (e.g., freedom from holes, protein content, biocompatibility). It references ASTM and ISO standards, which would typically specify sampling plans.
The data provenance is not explicitly stated in terms of country of origin but is presented as nonclinical test results performed on the device. Given the applicant is THAI HUA HOLDING CO., LTD. based in Bangkok, Thailand, it is reasonable to infer the tests were conducted in facilities related to their operations or authorized testing laboratories. The data appears to be retrospective as it's presented to demonstrate that the manufactured device meets established standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided in the document. The "ground truth" for the device's performance is established by its adherence to specified ASTM and ISO standards, which are themselves expert-developed and widely accepted.
4. Adjudication method for the test set:
This information is not provided. The assessment method relies on the device meeting numerical or qualitative criteria defined by the referenced standards, rather than expert adjudication of subjective outcomes.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
No, an MRMC comparative effectiveness study was not done. This device is a medical glove, not an AI-assisted diagnostic or imaging tool. Therefore, the concept of "human readers improve with AI" is not applicable here.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
No, a standalone algorithm performance study was not done. This device is a physical product (medical glove) and does not involve any algorithms or AI for its function.
7. The type of ground truth used:
The ground truth used is based on established national and international standards for medical gloves. Specifically:
- ASTM D 3578-05 Standard Specification for Rubber Examination Gloves for dimensions, physical properties, and freedom from holes.
- ASTM D 5151-06 for freedom from holes.
- ASTM D 5712-99 for protein content.
- ASTM D 6124-06 for powder-free residue.
- Consumer Product Safety Commissions Title 16, Chapter II. Part 1500.41& 1500:3(c)(4) for primary skin irritation.
- ISO 10993-10: 2002(E) for guinea pig sensitization.
These standards provide objective, measurable criteria which serve as the "ground truth" for the device's acceptable performance.
8. The sample size for the training set:
This concept is not applicable as the device is a physical product and does not involve machine learning or a "training set."
9. How the ground truth for the training set was established:
This concept is not applicable for the reasons stated in point 8.
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THAI HUA HOLDING COMPANY K 102840 LIMITED FEB 1 8 2011
| 510(k) SUMMARY OF SAFETY AND EFFECTIVENESSAs 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 proteinper square decimeter of gloves) | |
| 1. Applicant | THAI HUA HOLDING CO., LTD.238/1 Ratchadapisek 18, HuaykwangBangkok 10320 ThailandTel: 66-02-274 0471-7Fax: 66-02-274 0231 |
| 2. Contact Person | Mr. Reyong KittipolManaging DirectorTel: 66-02-2740 471-7Fax: 66-02-2740 231OrKok-Kee HonTechnical Advisor & Official Correspondent6324 Meetinghouse WayAlexandria, VA 22312 USATel: 703-941-7656Fax: 703-941-2551 |
| 3. Device Name: | Patient Examination Gloves |
| 4. Common Name: | Powder-Free Polymer Coated Latex Examination Gloves with ProteinLabeling (50microgram or less of total water extractable proteins per square decimeterof gloves) |
| 5. Classification: | Class 1 |
| 6. Predicate Device: | This glove is substantially equivalent to legally market Latex Patient ExaminationGloves, class 1 (21CFR 880.6250), product code LYY that meet all the requirements of ASTM D 3578-05 Standard Specification for Rubber Examination Gloves. |
| 7. Device Description: | Powder-Free Polymer Coated Latex Examination Gloves with ProteinLabeling (50microgram or less of total water extractable proteins per square decimeterof 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 preventcontamination between patient and examiner. |
| 9. Technological Characteristics of Device: | The Powder Free-Polymer Coated Latex Examination Gloves characteristics are summarized below ascompared 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 1.5Meets 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 SafetyCommissions Title 16, Chapter II. Part 1500.41& 1500:3(c)(4)Passes Guinea Pig Sensitization Test as per ISO 10993-10: 2002(E), Dermal SensitizationsAssay- Closed Patch Test |
| 10. Performance Data: | Are summarized above |
| 11. Clinical Data: | Not required |
| 12. Conclusion: | Powder-Free Polymer Coated Latex Examination Gloves with ProteinLabeling (50microgram or less of total water extractable proteins per square decimeter ofgloves) base on the nonclinical tests performed, this glove is as safe, as effective and performsat least as safely and effectively as the legally marketed predicate device identified or legallymarketed 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 (800) 638-2041 or (301) 796-7100 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
§ 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.