The subject device is a patient examination glove made of a synthetic nitrile latex compound. It is non-sterile, powder-free, with a polymer inner coating of aloe and Vitamin E (per 21 CFR 880.6250, Class I). The device can be either white or pink in color. The device is ambidextrous and can be worn on either the left or right hand. The device meets ASTM D6319-10: Standard Specification for Nitrile Examination Gloves for Medical Application.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Non-Sterile, Powder Free Nitrile Examination Gloves with Polymer Coating, Aloe, Vitamin E, White and Pink device, extracted from the provided document:

Acceptance Criteria and Device Performance

The device is a medical glove, and its performance is evaluated against established ASTM standards and general guidelines for medical gloves.

Table 1: Acceptance Criteria and Reported Device Performance

Characteristics	Acceptance Criteria/Standards	Reported Device Performance (Subject Device K142685)
Indications for Use	Medical Glove Guidance Manual	This is a medical device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
Device Design	-	A protective garment that covers the hand and wrist with openings for fingers and thumb.
Material	ASTM D6319-10	Nitrile Synthetic latex
Single Use	Medical Glove Guidance Manual	Single use
Ambidextrous	Medical Glove Guidance Manual	Ambidextrous
Sterility	Not applicable	Not applicable
Dimensions	ASTM D6319-10	Meets ASTM D6319-10 - Overall Length: 220 mm min (XS, S), 230 mm min (M, L, XL) - Width (+/- 10 mm): Size XS: 70 mm, Size S: 80 mm, Size M: 95 mm, Size L: 110 mm, Size XL: 120 mm - Thickness: Finger: 0.05 mm min, Palm: 0.05 mm min
Physical Properties	ASTM D6319-10 (aging= 70 +/- 2°C for 166 +/- 2 hrs; 100 +/- 2°C for 22 +/- 0.3 hrs)	Meets ASTM D6319-10 - Tensile Strength: 14 MPa min (before aging), 14 MPa min (after aging) - Ultimate Elongation: 500% min (before aging), 400% min (after aging)
Freedom from Pinholes	ASTM D5151-06	Meets AQL 2.5, Inspection Level G-1
Residual Powder	ASTM D6124-06	<2.0 mg/pc
Color	-	White and Pink
Labeling	Medical Glove Guidance Manual	Draft includes English only and lacks other minor elements pending completion of FINAL design; brand name(s) pending. (Note: Predicate includes English, French, and Spanish).
Biocompatibility	Primary Dermal Irritation in Rabbits and Guinea Pig Closed Patch Sensitization Test (ISO 10993-10)	Under the conditions of these studies, the test article was a non-irritant and non-sensitizer.

Study Information

This document is a 510(k) premarket notification, which demonstrates substantial equivalence to a legally marketed predicate device, rather than an independent clinical study proving new performance. Therefore, many of the typical clinical study details are not directly applicable.

Sample size used for the test set and the data provenance:
- The document does not specify a distinct "test set" in the context of a prospective clinical trial with human subjects. Instead, the device's physical properties are tested according to ASTM standards. The sample sizes for these standard tests (e.g., for dimensions, tensile strength, pinholes) are inherent to the specified ASTM methods, but not explicitly stated in this summary.
- Data Provenance: The testing was conducted by or on behalf of Siam Sempermed Corp., LTD, in Thailand, as indicated by the company's address. The data is retrospective in the sense that it's a summary of completed testing, not a prospective clinical trial.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable in the context of this 510(k) submission. "Ground truth" for physical properties is established by adherence to the objective criteria defined in the ASTM standards. For biocompatibility, the ground truth is established by the findings of the animal studies.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. Performance is measured objectively against specified physical and chemical standards.
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 a pair of examination gloves, not an AI-powered diagnostic or assistive tool.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical device (gloves).
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the device's performance is based on objective measurements and chemical analyses as defined by the referenced ASTM standards (e.g., D6319-10 for dimensions and physical properties, D5151-06 for pinholes, D6124-06 for residual powder) and ISO standard (10993-10 for biocompatibility).
The sample size for the training set:
- Not applicable. This is not a machine learning or AI device that requires a training set.
How the ground truth for the training set was established:
- Not applicable.

Summary Conclusion from the document:

The provided document, a 510(k) summary, concludes that the subject device is "substantially equivalent" to its predicate device (K121549) based on identical intended use, material, production process, and compliance with the same performance and biocompatibility standards. The only difference noted is the color (White and Pink for the subject device vs. Lavender Blue for the predicate). The "study" here is primarily a series of compliance tests against established industry standards and a comparison to a previously cleared device.

Summary

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

February 11, 2015

Siam Sempermed Corp., LTD c/o John Calhoun Manager of Regulatory Affairs Sempermed USA, Inc. 13900 49th Street North Clearwater, Florida 33762

Re: K142685

Trade/Device Name: Non-Sterile, Powder Free Nitrile Examination Gloves with Polymer Coating, Aloe, Vitamin E, White and Pink Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: January 9, 2015 Received: January 12, 2015

Dear Mr. Calhoun,

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.

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

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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 (OS) 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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Tejashri Purohit-Sheth, M.D.

Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR

Erin I. Keith, M.S. 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

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known) K142685

Device Name

Non-sterile, Powder free Nitrile Examination Glove with Polymer Coating, Aloe, Vitamin E. White and Pink

Indications for Use (Describe)

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

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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ATTACHMENT 5

510 (k) Summary

1.0 Submitter

Company name:	Siam Sempermed Corp., Ltd
Address:	10 Soi 10 Phetkasem Rd. HatyaiSongkhla. Thailand 90110
Phone:	(+66) 74 344 663
Fax:	(+66) 74 344 677
Contact Person:	Mr. Anan Pruksanusak (Managing Director)

2.0 Official Correspondent

Company name:	Sempermed USA Inc.
Address:	13900 49th Street NorthClearwater, USA , FL 33762
Phone:	727-787-7250
Fax:	727-787-7558
Contact person:	John V. Calhoun
3.0 Preparation Date:	September 11, 2014

4.0 Identification of Legally Marketed Predicate Device

Trade/Proprietary 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

510(k): K121549

Device name: Examination glove

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Device Classification Name: Patient Examination Gloves (21 CFR 880.6250) Device Class: Class 1 Product Code: LZA Classification Panel: General Hospital (Part 880)

5.0 Device description

The subject device is substantially equivalent to legally marketed Nitrile Examination Gloves identified as Product Code LZA.

6.0 Intended Use of Device

Non-sterile, Powder free Nitrile Examination Glove with Polymer Coating, Aloe, Vitamin E, White and Pink is a medical device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.

7.0 Summary of Technological Characteristics of Device and Comparison to Legally Marketed Predicate Device

Non-sterile, Powder free Nitrile Examination Glove with Polymer Coating, Aloe, Vitamin E, White and Pink is substantially equivalent to the predicate device, which differs only by color. A side-by side comparison of the predicate device with the subject device is presented in Table 1 on the following pages.

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

		Predicate: K121549	Subject device (K142685)
Characteristics	AcceptanceCriteria/Standards	Non-Sterile, Powder-freeNitrile Examination Glove withPolymer Coating. Aloe andVitamin E, Blue	Non-Sterile, Powder-freeNitrile Examination Glove withPolymer Coating. Aloe andVitamin E, White and Pink
Indications forUse	Medical Glove GuidanceManual	This is a medical deviceintended for medical purposesthat is worn on the examiner'shand to preventcontamination betweenpatient and examiner	This is a medical deviceintended for medical purposesthat is worn on the examiner'shand to preventcontamination betweenpatient and examiner
Device Design	-	A protective garment thatcovers the hand and wrist withopenings for fingers andthumb	A protective garment thatcovers the hand and wrist withopenings for fingers andthumb
Material	ASTM D6319-10	Nitrile Synthetic latex	Nitrile Synthetic latex
Single Use	Medical Glove GuidanceManual	Single use	Single use
Ambidextrous	Medical Glove GuidanceManual	Ambidextrous	Ambidextrous
Sterility	Not applicable	Not applicable	Not applicable
Dimensions	ASTM D6319-10	Meets ASTM D6319-10-Overall Length:220 mm min (XS, S)230 mm min (M, L, XL)-Width (+/- 10 mm)Size XS:70 mmSize S: 80 mmSize M: 95 mmSize L: 110 mmSize XL: 120 mm-Thickness:Finger: 0.05 mm minPalm: 0.05 mm min	Meets ASTM D6319-10-Overall Length:220 mm min (XS, S)230 mm min (M, L, XL)-Width (+/- 10 mm)Size XS:70 mmSize S: 80 mmSize M: 95 mmSize L: 110 mmSize XL: 120 mm-Thickness:Finger: 0.05 mm minPalm: 0.05 mm min
PhysicalProperties	ASTM D6319-10(aging= 70 +/- 2°C for 166 +/-2 hrs; 100 +/- 2° C for 22 +/-0.3 hrs)	Meets ASTM D6319-10(aging= 70 +/- 2°C for 166 +/- 2hrs; 100 +/- 2° C for 22 +/- 0.3hrs)-Tensile Strength:14 MPa min (before aging)14 MPa min (after aging)-Ultimate Elongation:500% min (before aging)400% min (after aging)	Meets ASTM D6319-10(aging= 70 +/- 2°C for 166 +/- 2hrs; 100 +/- 2° C for 22 +/- 0.3hrs)-Tensile Strength:14 MPa min (before aging)14 MPa min (after aging)-Ultimate Elongation:500% min (before aging)400% min (after aging)
Freedom fromPinholes	ASTM D5151-06	Meets AQL 2.5, InspectionLevel G-1	Meets AQL 2.5, InspectionLevel G-1
Residual Powder	ASTM D6124-06	<2.0 mg/pc	<2.0 mg/pc
Color	-	Lavender Blue	White and Pink
Labeling	Medical Glove Guidance Manual	Includes English, French, and Spanish languages	Draft includes English only and lacks other minor elements pending completion of FINAL design; brand name(s) pending
Biocompatibility	Primary Dermal Irritation in Rabbits and Guinea Pig Closed Patch Sensitization Test (ISO 10993-10)	Under the conditions of these studies, the test article was a non-irritant and non-sensitizer	Under the conditions of these studies, the test article was a non-irritant and non-sensitizer

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8.0. Conclusion:

The physical performance of the subject device (Nitrile Examination Gloves with Aloe & Vitamin E, Powder-free) is substantially equivalent to predicate K121549 and will perform according to the glove performance and biocompatibility standards referenced. Both are manufactured from the same nitrile synthetic latex material using the same production process. Only the colors differ. Based on the intended use, physical properties, and technological characteristics, the subject device is safe and effective as a legally marketed device.

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.