(169 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 Nitrile Examination Gloves (Blue), non-sterile.
Here's an analysis of the provided information regarding the acceptance criteria and the study proving the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance:
| CHARACTERISTICS | Acceptance Criteria (Standards) | Reported 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) ASTM D 5151-06 | Meets Meets AQL 1.5 |
| Powder Free Residual | ASTM 6124-06 | Less than 2 mg per glove |
| Biocompatibility: Primary Skin Irritation Test in Rabbits | Consumer Product Safety Commission, Title 16, Chapter II, Part 1500.41 & 1500:3(C)(4) | Passes |
| Biocompatibility: Guinea Pig Sensitization Test | ISO 10993-10: 2002(E), Dermal Sensitization Assay-Closed Patch Test | Passes |
Regarding the study proving the device meets the acceptance criteria, the provided document is a 510(k) summary for a medical device (Powder-Free Nitrile Examination Gloves). As such, it focuses on demonstrating substantial equivalence to a predicate device rather than a comprehensive clinical study report for an AI/imaging device. Therefore, many of the requested points below (sample size, experts, adjudication, MRMC, standalone performance, ground truth establishment) are not applicable in the context of this type of submission for examination gloves.
However, based on the information provided, we can infer the following about the testing and evidence:
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not explicitly stated. For physical property testing of gloves, sample sizes are typically defined by the specific ASTM standards (e.g., a certain number of gloves per batch for dimension, tensile strength, and freedom from holes testing).
- Data Provenance: Not explicitly stated, but based on the nature of manufacturing and testing for medical devices, it would be retrospective data collected during the production and quality control processes of the manufacturer (THAI HUA HOLDING COMPANY LIMITED). The country of origin of the data would likely be Thailand, where the manufacturer is located, or potentially the location of the testing laboratories.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:
- Not Applicable. For physical and biocompatibility testing of gloves, "experts" in the sense of clinician reviewers establishing ground truth for disease detection are not relevant. The "ground truth" is objective measurement against specified standards. Testing would be performed by lab technicians or engineers trained in the relevant ASTM and ISO standards.
4. Adjudication Method for the Test Set:
- Not Applicable. As the "ground truth" relies on objective measurements against standards, an adjudication method for different human interpretations is not needed. Test results either meet the numerical criteria or they don't.
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:
- Not Applicable. This device is an examination glove, not an AI or imaging device that would involve human readers or AI assistance.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not Applicable. See point 5.
7. The type of ground truth used:
- Objective Measurements/Standards: The ground truth for this device's performance is established by the specified ASTM (American Society for Testing and Materials) and ISO (International Organization for Standardization) standards, and Consumer Product Safety Commission regulations. For example:
- Dimensions and Physical Properties: Direct measurements of glove size, tensile strength, elongation, etc., compared against the numerical ranges defined in ASTM D 6319-00a(2005).
- Freedom from Holes: Water leak testing as per ASTM D 5151-06, yielding a quantified Acceptable Quality Level (AQL).
- Powder Free Residual: Measurement of residual powder, compared against the limit in ASTM 6124-06.
- Biocompatibility: Results from standardized animal (rabbit, guinea pig) tests for irritation and sensitization, evaluated against established toxicology protocols.
8. The Sample Size for the Training Set:
- Not Applicable. This is not an AI/machine learning device that requires a "training set." The testing methods are based on established engineering and materials science principles.
9. How the Ground Truth for the Training Set was Established:
- Not Applicable. See point 8.
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THAI HUA HOLDING COMPANY LIMITED
| 510(k) SUMMARY OF SAFETY AND EFFECTIVENESSAs 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: 66-02-274 0471-7 | |
| Fax: 66-02-274 0231 | |
| 2. Contact Person: | Mr. Reyong Kittipol |
| Managing Director | |
| Tel: 66-02-2740 471-7 | |
| Fax: 66-02-2740 231 | |
| Or | |
| Kok-Kee Hon | |
| Technical Advisor & Official Correspondent | |
| 6324 Meetinghouse Way | |
| Alexandria, VA 22312 USA | |
| Tel: 703-941-7656 | |
| Fax: 703-941-2551 | |
| 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)ASTM D 5151-06 | MeetsMeets AQL 1.5 |
| Powder Free Residual | ASTM 6124-06 | Less than 2 mg per glove |
| BiocompatibilityPrimary Skin IrritationTest in Rabbits | Consumer Product Safety Commission, Title16, Chapter II, Part 1500.41& 1500:3(C)(4) | Passes |
| BiocompatibilityGuinea PigSensitization Test | ISO 10993-10: 2002(E), Dermal SensitiztionAssay-Closed Patch Test | Passes |
-
Performance Data Arc summarized above
-
Clinical Data: Not required
-
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
- 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 (800) 638-2041 or (301) 796-7100 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
§ 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.