(142 days)
Not Found
Not Found
No
The device is a standard examination glove and the summary contains no mention of AI or ML technology.
No.
This device is an examination glove, intended to prevent contamination between the patient and the examiner, which is a prophylactic measure rather than a therapeutic treatment.
No
Explanation: The device is a glove intended to prevent contamination between the patient and examiner, not to diagnose any condition or disease. Its function is barrier protection.
No
The device is a physical examination glove, not a software application. The description clearly outlines its material, physical properties, and performance standards related to a tangible product.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the glove is for preventing contamination between patient and examiner by being worn on the hand. This is a physical barrier function, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details the physical characteristics of the glove (material, coating, protein content, sterility). It doesn't mention any components or features related to analyzing biological samples.
- Lack of IVD Indicators: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring specific substances (analytes)
- Providing information for diagnosis, monitoring, or screening of diseases or conditions.
This device is a medical glove, which falls under a different regulatory classification than IVDs.
N/A
Intended Use / 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.
Product codes
LYY
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
examiner
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
The Powder Free-Polymer Coated Latex Examination Gloves characteristics are summarized below as compared to ASTM requirements and to predicate devices:
Characteristic: Dimensions, Standard: Meets ASTM D 3578-05
Characteristic: Physical Properties, Standard: Meets ASTM D 3578-05
Characteristic: Freedom From Holes, Standard: Meets ASTM D 3578-05, AQL 1.5; Meets ASTM D 5151-06
Characteristic: Protein Content, Standard: Meets ASTM D 5712-99, Less than 50µg/dm²
Characteristic: Powder Free Residue, Standard: Meets ASTM D 6124-06, Less than 2 mg per glove
Characteristic: Biocompatibility, Standard: Passes Primary Skin Irritation in Rabbits Test as described in Consumer Product Safety Commissions Title 16, Chapter II. Part 1500.41& 1500:3(c)(4); Passes Guinea Pig Sensitization Test as per ISO 10993-10: 2002(E), Dermal Sensitizations Assay- Closed Patch Test
Key Metrics
Not Found
Predicate Device(s)
This glove is substantially equivalent to legally market Latex Patient Examination Gloves, class 1 (21CFR 880.6250), product code LYY that meet all the requirements of ASTM D 3578-05 Standard Specification for Rubber Examination Gloves.
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
THAI HUA HOLDING COMPANY K 102840 LIMITED FEB 1 8 2011
| 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
| As 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 protein | |
| per square decimeter of gloves) | |
| 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 Polymer Coated Latex Examination Gloves with Protein |
| Labeling (50microgram or less of total water extractable proteins per square decimeter | |
| of gloves) | |
| 5. Classification: | Class 1 |
| 6. Predicate Device: | This glove is substantially equivalent to legally market Latex Patient Examination |
| Gloves, 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 Protein |
| Labeling (50microgram or less of total water extractable proteins per square decimeter | |
| of 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 prevent |
| contamination between patient and examiner. | |
| 9. Technological Characteristics of Device: | The Powder Free-Polymer Coated Latex Examination Gloves characteristics are summarized below as |
| compared 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 1.5 |
| Meets 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 Safety |
| Commissions Title 16, Chapter II. Part 1500.41& 1500:3(c)(4) | |
| Passes Guinea Pig Sensitization Test as per ISO 10993-10: 2002(E), Dermal Sensitizations | |
| Assay- Closed Patch Test | |
| 10. Performance Data: | Are summarized above |
| 11. Clinical Data: | Not required |
| 12. Conclusion: | Powder-Free Polymer Coated Latex Examination Gloves with Protein |
| Labeling (50microgram or less of total water extractable proteins per square decimeter of | |
| gloves) base on the nonclinical tests performed, this glove is as safe, as effective and performs | |
| at least as safely and effectively as the legally marketed predicate device identified or legally | |
| marketed Latex Patient Examination Gloves. Class I (21CFR 880.6250), product code LYY. |
1
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.
2
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
3
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