NON-STERILE, POWDER FREE LATEX EXAMINATION GLOVES AND PROTEIN CLAIM (50 MICROGRAMS OR LESS) MODEL: WHITE: X-SMALL, SMALL

• K Number: K100907
• Device Name: NON-STERILE, POWDER FREE LATEX EXAMINATION GLOVES AND PROTEIN CLAIM (50 MICROGRAMS OR LESS) MODEL: WHITE: X-SMALL, SMALL
• Manufacturer: SIAM SEMPERMED CORP. LTD.
• Date Cleared: 2010-07-09 ( 99 days)
• Product Code: LYY
• Regulation Number: 880.6250

Intended Use

A 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.

Device Description

Non-Sterile, powder-free latex examination gloves and protein claim (50 micrograms or less).

Predicate Devices

K970794

Reference Devices

K970794

AI/ML (Artificial Intelligence / Machine Learning)

No
The device is a simple examination glove and the summary contains no mention of AI, ML, or related concepts.

Therapeutic

No
The device is described as "a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner," which indicates it is a barrier device, not one for therapy.

Diagnostic

No

Explanation: The device is a patient examination glove, described as a disposable device worn for "preventing contamination between patient and examiner." Its intended use does not involve diagnosing medical conditions or diseases.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a physical product (gloves) and does not mention any software components.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• Intended Use: The intended use is clearly stated as a "disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner." This describes a barrier device used for infection control during physical examinations.
• IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections. This device does not perform any such testing.
• Device Description: The description focuses on the physical characteristics of the glove (latex, powder-free, protein claim) and its function as a barrier.
• Lack of IVD-related information: There is no mention of analyzing samples, detecting biomarkers, or any other activity associated with in vitro diagnostics.

Therefore, this device falls under the category of a medical device used for barrier protection, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

This device is a disposable device intended for medical purpose that is worn on the examiner 's hand to prevent contamination between patient and examiner.
A 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.

Product codes

LYY

Device Description

Non-Sterile, powder-free latex examination gloves and protein claim (50 micrograms or less).

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

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

The performance test data of the non-clinical tests that support a determination of substantial equivalence is the same as mentioned immediately above.
Non-Sterile, powder-frec latex examination gloves and protein claim (50 micrograms or less) will perform according to the glove performance standards referenced in section 17 above and meet ASTM standards, and FDA requirements.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K970794

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 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.

Summary

0

JUL·- 9 2010

510 (k) Summary As Required by 21 section 807.92 ( c)

• 1. Submitter Name: Siam Sempermed Corp., Ltd
• 2. Address: 352 Kanjanavanit Road. Pahtong Hatyai Songkhla. Thailand 90230
• ([phone]. Phone:
• 4. Fax: [phone]
• 5. Contract Person: Mrs. Parawan Paiyasan (Quality System manager)

6. Date summary prepared: 15 March , 2010

• 7. Official Correspondent: Sempermed USA Inc.
• 13900 49th Street North 8. Address: Clearwater, USA , FL 33762
• 727 787 7250 9. Phone:
• 10. Fax: [phone]
• Mr. William E. Harris 11. Contact person:
• 12. Device Trade or Proprietary Name: Non-sterile, powder-free latex examination gloves and protein claim (50 micrograms or less).
• 13. Device Common or usual name: Examination glove
• 14. Device Classification Name: Glove , Patient Examination , Latex
• 15. Description of the Device:

Non-Sterile, powder-free latex examination gloves and protein claim (50 micrograms or less). 16. Intended use of the device:

This device is a disposable device intended for medical purpose that is worn on the examiner 's hand to prevent contamination between patient and examiner.

17. Summary of The Technological Characteristics of The devices :(According Guidance for Industry and FDA Staff - Medical Glove Guidance Manual(January 22, 2008))

Non-Sterile, powder-free latex examination gloves and protein claim (50 micrograms or less) are summarized with the following technological characteristics:

CHARACTERISTICS	STANDARDS	DEVICE PERFORMANCE
Dimensions: overall length; width, palm
and finger thickness	ASTM D 3578-05-e1	Meets
Tensile strength: before and after aging	ASTM D 3578-05-el	Meets
Ultimate elongation: before and after
aging	ASTM D 3578-05-e1	Meets
Freedom from holes: pinholes AQL 2.5	ASTM D 3578-05-e1	Meets
Powder Free Residue	ASTM D 3578-05-e1	Meets
Protein Level	ASTM D 3578-05-e1	Meets
Biocompatability	Primary Skin Irritation in
Rabbits	Passes
	Guinea Pig Sensitization	Passes

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18. 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 immediately above.

19. Conclusion

It can be concluded that Non-Sterile, powder-frec latex examination gloves and protein claim (50 micrograms or less) will perform according to the glove performance standards referenced in section 17 above and meet ASTM standards, and FDA requirements. Consequently, this device is substantially equivalent to currently marketed devices. This device is safe and effective as the predicate device Siam Sempermed Latex Pattent Examination Glove , Powder free and protein claim (50 micrograms or less). Indeed , it is equivalent. This is better expressed in the tabulated comparison as below.

Technical comparison of specific elements is attached in the main submission.

FDA file reference number	510k number : K970794
Attachments inside notification
submission file	REFER TO APPENDIX I
TECHNOLOGICAL
CHARACTERISTICS	Comparison result
REFER TO ADDITIONAL TECHNICAL
COMPARATIVE TABLE WITHIN 510K
SUBMISSION
Indications for use	Identical
Target population	Identical
Design	Identical
Materials	Similar
Performance	Identical
Sterility	Not applicable
Biocompatibility	Identical
Mechanical safety	Identical
Chemical safety	Identical
Anatomical sites	Identical
Human factors	Identical
Energy used and/or delivered	Identical (Not applicable)
Compatibility with environment
and other devices	Identical
Where used	Identical
Standards met	Identical
Electrical safety	Identical (Not applicable)
Thermal safety	Identical (Not applicable)
Radiation safety	Identical (Not applicable)

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SEP 9 2010 Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Siam Sempermed Corporation, Limited C/O Mr. William E. Harris President & Chief Executive Office Sempermed USA, Incorporated 13900 49th Street North Clearwater, Florida 33762

Re: K100907

Trade/Device Name: Non-Sterile, Powder-Free Latex Examination Glove with Protein Claim (50 micrograms or less) Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYY Dated: June 16, 2010 Received: June 22, 2010

Dear Mr. Harris:

This letter corrects our substantially equivalent letter of July 9, 2010.

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 (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.

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. Harris

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/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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Anthony D. wat
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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Indications for Use

K100907 510(k) Number (if known):

Device Name: Non-Sterile, Powder-Free Latex Examination Glove with Protein Claim (50 micrograms or less).

Indications For Use: A 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.

(Division Sign-Off) Division of Anesthesiology. General Hospital Infection Control, Dental Devices

KIDO907 510(k) Number:

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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