The provided text describes a 510(k) summary for a Nitrile Examination Glove, not a medical imaging AI device. Therefore, it does not contain information related to acceptance criteria, study methodologies (like sample size, ground truth establishment, expert adjudication, MRMC studies, or standalone performance) typically associated with the development and validation of AI models for medical imaging.

The document focuses on demonstrating substantial equivalence of a new glove product to existing predicate devices based on material, intended use, physical properties, and biocompatibility.

Therefore, I cannot extract the requested information as it is not present in the provided text.

If you have a document describing an AI device for medical imaging, please provide that, and I will be happy to extract the relevant details.

Summary

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ATTACHMENT 1

K121549

510 (k) Summarv

As Required by 21 section 807.92 (c)

Submitter Name: Siam Sempermed Corp., Ltd 1.
10 Soi 10 Phetkasem Rd. Hatvai 2. Address: Songkhla. Thailand 90110
1. Phone: (+66) 74 344 663
(+66) 74 344 677 4. Fax:

Mr. Anan Pruksanusak (Chief Operations Officer) 5. Contract Person:

Date summary prepared: December 5, 2012 6.
Official Correspondent: Sempermed USA Inc. 7.
13900 49th Street North 8. Address: Clearwater, USA , FL 33762
727-787-7250 9. Phone:
727-787-7558 10. Fax:
1. Contact person: Mr. William E. Harris, III

Device Trade or Proprietary Name: Nitrile Examination Gloves with Aloe & Vitamin E, Powder-Free
Device Common or usual name: Examination glove

1. Device Classification Name: Polymer patient examination glove
1. Device Class: Class 1

Product Code: LZA
Description of the Device: Non-sterile, Powder-free Nitrile Examination Glove with Polymer coating, Aloe and Vitamin E. Blue.

18. Intended use of the device:

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

19. Predicate devices:

K083755: Non-Sterile, Powder-Free Nitrile Examination Glove with Polymer Coating. Tested for a. use with Chemotherapy Drugs [core glove].
K024121: Non-Sterile, Powder-Free Latex Examination Gloves with Polymer Coating, Aloe, b. Vitamin E and Protein Claim (50 micrograms or Less) [Aloe & Vitamin E coating].

20. Summary of the Technological Characteristics:

Non sterile, Powder free Nitrile Examination Glove with Polymer coating, Aloe, Vitamin E, Blue is substantially equivalent to the predicate devices. A side-by side comparison of the predicate devices with the subject device is presented in Table 1.

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Table 1. Side-by-side Comparison of Predicate Devices with Subject Device

Device Description	Predicate 1: K083755	Predicate 2: K024121	Subject device	SubstantialEquivalence
	Non-Sterile, Powder Free	Non-Sterile, Powder-Free	Non-Sterile, Powder-
	Nitrile Blue Examination	Latex Examination	Free Nitrile Examination
	Glove with Polymer	Gloves with Polymer	Gloves with Polymer
	Coating. Tested for use	Coating, Aloe, Vitamin E	Coating, Aloe and
	with Chemotherapy Drugs	and Protein Claim (50	Vitamin E, Blue
	[core glove]	micrograms or Less [aloe& vitamin E coating]
Intended Use	This is a medical device	This is a medical device	This is a medical device
	intended for medical	intended for medical	intended for medical
	purposes that is worn on	purposes that is worn on	purposes that is worn on
	the examiner's hand to	the examiner's hand to	the examiner's hand to	SE
	prevent contamination	prevent contamination	prevent contamination
	between patient and	between patient and	between patient and
	examiner	examiner	examiner
Device Design	A protective garment that	A protective garment that	A protective garment
	covers the hand and wrist	covers the hand and wrist	that covers the hand and	SE
	with openings for fingers	with openings for fingers	wrist with openings for
	and thumb	and thumb	fingers and thumb
PrimaryCompound Used	Nitrile Synthetic latex	Natural Rubber Latex	Nitrile Synthetic Latex	SE
Single Use	Yes	Yes	Yes	SE
Ambidextrous	Yes	Yes	Yes	SE
Sterility	Not applicable	Not applicable	Not applicable	SE
Biocompatibility	Passes Primary Dermal	Passes Primary Dermal	Passes Primary Dermal
	Irritation in Rabbits and	Irritation in Rabbits and	Irritation in Rabbits and
	Guinea Pig Closed Patch	Guinea Pig Closed Patch	Guinea Pig Closed Patch	SE
	Sensitization Test (ISO	Sensitization Test (ISO	Sensitization Test (ISO
	10993-10)	10993-10)	10993-10)
Dimensions	Meets ASTM D6319-10	Meets ASTM D3578-05	Meets ASTM D6319-10	SE
Tensile Strength	Meets ASTM D6319-10	Meets ASTM D3578-05	Meets ASTM D6319-10	SE
UltimateElongation	Meets ASTM D6319-10	Meets ASTM D3578-05	Meets ASTM D6319-10	SE
Freedom fromPinholes	Meets ASTM D5151-6	Meets ASTM D5151-6	Meets ASTM D5151-6	SE
Residual Powder	Meets ASTM D6124	Meets ASTM D6124	Meets ASTM D6124	SE
Polymer Coating	Yes	Yes	Yes	SE
Color	Lavender Blue	Natural	Blue	SE
Labeling	Includes chemotherapyclaim	Includes Aloe andVitamin E claim	Includes Aloe andVitamin E claim	SE
Aloe & Vitamin E	No	Yes	Yes. Same proprietary	SE

19. Conclusion:

The physical performance characteristics of the subject device (Non-Sterile, Powder free Nitrile Examination Glove with Polymer coating, Aloe, and Vitamin E, Blue) is substantially equivalent to predicate K083755 and will perform according to the glove performance standards referenced. Both are manufactured from the same nitrile synthetic latex material using the same production process. The subject device lacks the chemotherapy claim of predicate K083755. Although predicate K024121 is composed of natural rubber latex, it is treated with the same Aloe and Vitamin E coating mixture as the subject device is therefore considered to be substantially equivalent to currently marketed devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized graphic of three human figures in profile, stacked on top of each other. The figures are black and have a flowing, abstract design. The graphic is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

December 27, 2012

Siam Sempermed Corporation, Limited C/O Mr. William E. Harris President and Chief Executive Officer Sempermed USA. Incorporated 13900 49th Street North CLEARWATER FL 33762

Re: K121549

Trade/Device Name: Nitrile Examination Gloves with Aloe & Vitamin E, Powder-Free Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: December 14, 2012 Received: December 20, 2012

Dear Mr. Harris:

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. 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 devicerelated 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 (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Kwame O. Ulmer

Anthony D. Watson, B.S., M.S., M.B.A. Director

Division of Anesthesiology, General Hospital, Respiratory. Infection Control and

Dental Devices

Office of Device Evaluation

Center for Devices and

Radiological Health

Enclosure

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ATTACHMENT 6

K121549

Indications for Use

510(k) Number (if known): K121549

Device Name: Nitrile Examination Gloves with Aloe & Vitamin E, Powder-Free

Device Description: Non-sterile, Powder-free Nitrile Examination Glove with Polymer Coating, Aloe, and Vitamin E, Blue

Indications For Use:

Indications For Use: This is a medical device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner

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)

Maria Cruz-
fisher

Digitally signed by Maria Cruz-fisher DN: c=US, o=U.S. Government, ou=H FDA, OI ople, cn=Mari

0.9 2342.19200300.100.1.1=2000576169 Date: 2012.12.27 10:52:14 -0510

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

Page 1 of

510(k) Number:

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.