The Disposable Nitrile Examination Gloves (Powder free, Purple-Blue, Blue) is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.

Device Description

The proposed device, Disposable Nitrile Examination Gloves (Powder free, Purple-Blue, Blue) are disposable devices intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner. The proposed devices are Powder Free Nitrile Examination Gloves and includes variations of different size and color. The color of the proposed device is Blue and Purple-Blue. The proposed device is not provided as sterilized. The proposed device is made of Nitrile.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided FDA 510(k) summary for Disposable Nitrile Examination Gloves.

Important Note: This document pertains to the clearance of a medical device – specifically disposable nitrile examination gloves. The concepts of "AI models," "human readers," "effect size," "multi-reader multi-case (MRMC) comparative effectiveness studies," "standalone algorithms," and "ground truth establishment for training sets" as typically applied to AI/ML medical devices do not apply to this product. This submission focuses on the physical and performance characteristics of the gloves themselves compared to a predicate device.

Therefore, the answers to several of your requested points will be "Not Applicable" or refer to standard laboratory testing rather than AI/ML model validation.

1. Table of Acceptance Criteria and Reported Device Performance

Device: Disposable Nitrile Examination Gloves (Powder free, Purple-Blue, Blue)

Test Method	Purpose	Acceptance Criteria	Reported Device Performance (Worst Case/Representative)
ASTM D5151	Freedom from Holes	AQL 2.5	Blue Color: No water leakage inspected from 200 samples (Meets AQL 2.5)Purple-Blue Color: No water leakage inspected from 200 samples (Meets AQL 2.5)
ASTM D6124	Residual Powder for Powder-Free Gloves	<2.0 mg per glove	Blue Color: Avg. 0.29 mg (XS), 0.32 mg (S), 0.39 mg (M), 0.34 mg (L), 0.38 mg (XL)Purple-Blue Color: Avg. 0.33 mg (XS), 0.32 mg (S), 0.32 mg (M), 0.37 mg (L), 0.38 mg (XL)(All values are significantly less than 2.0 mg/glove)
ASTM D412, D573	Physical Property Characteristics	Before Aging: Tensile Strength: ≥ 14 MPa, Ultimate Elongation: ≥ 500%After Aging: Tensile Strength: ≥ 14 MPa, Ultimate Elongation: ≥ 400%	Blue Color: Before Aging: Tensile Strength: ≥ 19 MPa, Ultimate Elongation: ≥ 500%. After Aging: Tensile Strength: ≥ 17.8 MPa, Ultimate Elongation: ≥ 472%.Purple-Blue Color: Before Aging: Tensile Strength: ≥ 19 MPa, Ultimate Elongation: ≥ 500%. After Aging: Tensile Strength: ≥ 17.1 MPa, Ultimate Elongation: ≥ 463%.(All values exceed the minimum acceptance criteria)
ASTM D412, D3767	Physical Dimensions Specification	Length: ≥ 220 mm (XS, S), ≥ 230 mm (M, L, XL)Width: 70±10 mm (XS), 80±10 mm (S), 95±10 mm (M), 110±10 mm (L), 120±10 mm (XL)Cuff Thickness: ≥0.05 mm; Finger Thickness: ≥0.05 mm; Palm Thickness: ≥0.05 mm. (All meet ASTM D6319 requirements)	Blue Color (Representative for XS): Length: ≥ 230 mm; Width: 75±3 mm (75-78 mm); Cuff/Palm/Finger Thickness: ≥0.06 mm/≥0.07 mm/≥0.10 mm respectively.Purple-Blue Color (Representative for XS): Length: ≥ 230 mm; Width: 75±4 mm (75-79 mm); Cuff/Palm/Finger Thickness: ≥0.05 mm/≥0.07 mm/≥0.08 mm respectively.(All reported dimensions across all sizes and colors consistently meet or exceed the specified minimums and ranges)
ISO 10993-11	Systemic Toxicity (Biocompatibility)	No evidence of systemic toxicity from the extract.	The test article showed no evidence of systemic toxicity from the extract.
ISO 10993-10	Irritation (Biocompatibility)	The response of the test article extract is negligible.	The test result showed that the response of the test article extract was categorized as negligible under the test condition.
ISO 10993-10	Sensitization (Biocompatibility)	No evidence of causing delayed dermal contact sensitization.	The test article showed no evidence of causing delayed dermal contact sensitization in the guinea pig.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Physical/Performance Tests:
- Freedom from Holes (ASTM D5151): 200 samples were inspected for each color (Blue and Purple-Blue). This is per the standard's sampling requirements for AQL testing.
- Residual Powder (ASTM D6124): Quantities of powder were measured across various sizes (XS, S, M, L, XL) for both colors. The exact number of gloves per size/color tested isn't explicitly stated but would be based on the ASTM D6124 standard.
- Physical Property Characteristics (Tensile Strength, Elongation): Not explicitly stated, but standard test methods (ASTM D412, D573) specify the number of specimens to be tested per batch.
- Physical Dimensions: Not explicitly stated, but standard test methods (ASTM D412, D3767) specify the number of specimens to be measured.
- Biocompatibility Tests (ISO 10993-10, -11): These tests involve a specific number of animal subjects (e.g., guinea pigs for sensitization, mice for systemic toxicity, rabbits for irritation). The exact number isn't in the summary but is defined by the ISO standards.
Data Provenance: The tests appear to be internal bench tests conducted by or for the manufacturer. No specific country of origin for the test data is given beyond the company's location (China). These are prospective tests performed specifically for this 510(k) submission, not retrospective data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Not Applicable. This is not an AI/ML device where "ground truth" is established by human experts reviewing medical images. The "ground truth" here is the objective measurement against established ASTM and ISO standards for physical properties, chemical residue, and biological safety of gloves. These measurements are performed by trained technicians in a laboratory setting, not by medical experts interpreting data like radiologists.

4. Adjudication Method for the Test Set

Not Applicable. As this is not an AI/ML device; there is no human interpretation or adjudication involved in the test results. The tests are objective measurements against pre-defined quantitative criteria.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

Not Applicable. MRMC studies are used to assess the impact of AI on human reader performance, typically in imaging diagnostics. This device is a physical product (gloves) and does not involve human readers interpreting AI output.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not Applicable. This is not an algorithm or AI model. Its performance is measured directly through physical, chemical, and biological testing.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established by:

Reference Standards: Adherence to established and internationally recognized industry standards (ASTM D6319, D5151, D6124, ISO 10993-10, ISO 10993-11).
Laboratory Measurements: Objective measurements of physical properties (e.g., length, width, thickness, tensile strength, elongation), chemical properties (residual powder), and biological responses (irritation, sensitization, systemic toxicity) using calibrated equipment and validated protocols.

8. The Sample Size for the Training Set

Not Applicable. This product is not an AI/ML model, and therefore, there is no "training set." The product's characteristics are inherent to its manufacturing process and materials, and its performance is validated through defined testing, not a learned model.

9. How the Ground Truth for the Training Set was Established

Not Applicable. As there is no training set for this type of device, this question is irrelevant.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. Underneath the square are the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

August 26, 2021

Tangshan Lanhai Medical Supplies Co., Ltd. % Ray Wang General Manager Beijing Believe-Med Technology Service Co., Ltd. Rm. 912, Building #15, XiYueHui, No. 5, YiHe North Rd., FangShan District Beijing, Beijing 102401 China

Re: K210898

Trade/Device Name: Disposable Nitrile Examination Gloves (Powder Free, Purple-Blue, Blue) Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA Dated: June 1, 2021 Received: June 4, 2021

Dear Ray Wang:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

For Clarence W. Murray III, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.

510(k) Number (if known) K210898

Device Name

Disposable Nitrile Examination Gloves (Powder free, Purple-Blue, Blue)

Indications for Use (Describe)

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

Prescription Use (Part 21 CFR 801 Subpart D)

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.

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510(k) Summary K210898

This 510(k) Summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and 21 CFR 807.92.

The assigned 510(k) Number: K210898

1. Date of Preparation: 08/24/2021
1. Sponsor

Tangshan Lanhai Medical Supplies Co., Ltd.

South Side of Zhongda Street, East Side of Jinxiu Road, Chengxi Industrial Zone, Luannan County, Tangshan City, Hebei Province, P.R. China 063500 Contact Person: Li Ruidong Position: Manager Tel: +86-15931581811 Fax: +86-315-4155192 Email: 718356353@qq.com

Submission Correspondent 3.
Beijing Believe-Med Technology Service Co., Ltd. Rm.912, Building #15, XiYueHui, No.5, YiHe North Rd., FangShan District, Beijing, China,102401 Tel: +86-18910677558 Fax: +86-10-56335780 Email: ray.wang@believe-med.com
Proposed Device Identification 4.
Trade Name: Disposable Nitrile Examination Gloves (Powder free, Purple-Blue, Blue) Common Name: NITRILE Patient Examination Gloves (Powder Free) Regulatory Information: Classification: I Product Code: LZA Regulation Number: 21 CFR 880.6250 Review Panel: General Hospital

Indication For Use Statement:

న్న Predicate Device Identification

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510(k) Number: K150340

Product Name: POWDER FREE Nitrile GLOVES (White, Cobalt Blue, Black, Ice Blue) Manufacturer: HEBEI HONGSEN PLASTICS TECHNOLOGY CO., LTD

Device Description 6.
The proposed device, Disposable Nitrile Examination Gloves (Powder free, Purple-Blue, Blue) are disposable devices intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.

The proposed devices are Powder Free Nitrile Examination Gloves and includes variations of different size and color. The color of the proposed device is Blue and Purple-Blue.

The proposed device is not provided as sterilized

The proposed device is made of Nitrile.

Designation	Size					Tolerance
	XS	S	M	L	XL
Length, mm	220	220	230	230	230	min
Width, mm	70	80	95	110	120	±10
Thickness, mm:
Finger	0.05					min
Palm	0.05					min
Cuff	0.05					min

Table 1 Device Size Specifications

Before Aging		After Aging		Pinhole AQL
TensileStrength	UltimateElongation	TensileStrength	UltimateElongation
14 MPa, min	500 % min	14 MPa, min	400 % min	2.5

Table 2 Performance and Physical Specifications

The above data of size, performance, and physical specifications of proposed gloves meet all the current specifications listed in the ASTM standard D6319.

1. Comparison of technological characteristics between the subject and predicate devices

ITEM	Proposed Device (K210898)	Predicate Device (K150340)	Remark
	Disposable Nitrile Examination Gloves(Powder free, Purple-Blue, Blue)	POWDER FREE Nitrile GLOVES (White,Cobalt Blue, Black, Ice Blue)
Product Code	LZA	LZA	SAME
Regulation No.	21 CFR 880.6250	21 CFR 880.6250	SAME

Table 1 General Comparison

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Class	I	I	SAME
IntendedUse/IndicationFor Use	The Disposable Nitrile Examination Gloves(Powder free, Purple-Blue, Blue) is adisposable device intended for medicalpurposes that is worn on the examiner'shands to prevent contamination betweenpatient and examiner.	The POWDER FREE Nitrile GLOVES(White, Cobalt Blue, Black, Ice Blue) is adisposable device intended for medicalpurposes that is worn on the examiner'shands to prevent contamination betweenpatient and examiner.	SAME
	Powdered orPowered free	Powdered free	Powdered free	SAME

Proposed Device (K210898)		Size					Tolerance
Disposable Nitrile ExaminationGloves (Powder free,Purple-Blue, Blue)		Designation	XS	S	M	L	XL
		Length, mm	220	220	230	230	230	min
		Width, mm	70	80	95	110	120	±10
		Thickness, mm:
		Finger	0.05					min
		Palm	0.05					min
		Cuff	0.05					min
Predicate Device (K150340)		Size
POWDER FREE NitrileGLOVES (White, Cobalt Blue,Black, Ice Blue)		Designation	XS	S	M	L	XL	Tolerance
		Length, mm	230	230	230	230	230	min
		Width, mm	70	80	95	110	120	±10
		Thickness, mm:
		Finger	0.10-0.12					±0.03
		Palm	0.08-0.10					±0.03
		Cuff	0.06-0.09					±0.03
Remark	Similar

Table 2 Device Dimensions Comparison

Different Analysis:

The proposed device has different size specification to the predicate device, but all proposed devices are meet the specifications of ASTM D 6319.

ITEM	Proposed Device (K210898)Disposable Nitrile Examination Gloves(Powder free, Purple-Blue, Blue)	Predicate Device (K150340)POWDER FREE Nitrile GLOVES(White, Cobalt Blue, Black, IceBlue)	Remark
Colorant	Blue, Purple Blue	White, Cobalt Blue, Black, Ice Blue	Different

Table 3 Performance Comparison

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Single Use			Yes	Yes	SAME
PhysicalProperties	BeforeAging	TensileStrength	14 MPa, min	15 MPa, min	Different
		UltimateElongation	500 % min	500 % min	SAME
	AfterAging	TensileStrength	14 MPa, min	14 MPa, min	SAME
		UltimateElongation	400 % min	400 % min	SAME
Freedom from Holes			Comply with ASTM D6319	Comply with ASTM D6319	SAME
			Be free from holes when tested inaccordance with ASTM D5151, AQL2.5	Be free from holes when tested inaccordance with ASTM D5151,AQL 1.5	Different
Powder Content			Less than 2 mg per glove when testedin accordance with ASTM D6124	Meet the requirements of ASTM6124	SAME

Different Analysis:

The proposed device has different color to the predicate device, this different may causes potential biocompatibility risk, for this risk we conducted the biocompatibility test according to the ISO 10993-10 and ISO 10993-11 and the test results showed that the proposed devices did not induce skin irritation and showed no significant evidence of causing skin sensitization and systemic toxicity response.

Different Analysis:

The proposed device has different Tensile Strength before aging specification to the predicate device, but all proposed device meets the specification requirements of ASTM D 6319.

Different Analysis:

The proposed device has different AQL to the predicate device, but all proposed device meets the specification requirements of ASTM D 6319.

ITEM	Proposed Device	Predicate Device (K150340)	Remark
	Disposable Nitrile ExaminationGloves (Powder free, Purple-Blue,Blue)	POWDER FREE Nitrile GLOVES(White, Cobalt Blue, Black, IceBlue)
Material used	Nitrile	Nitrile	SAME
Biocompatibility	Irritation	Under the conditions of the study,not an irritant	Under the conditions of the study,not an irritant	SAME
	Sensitization	Under conditions of the study, not asensitizer.	Under conditions of the study, not asensitizer.
	acutesystemic	Under the conditions of the study,there was no evidence of systemic	Not Available	Different

Table 4 Safety Comparisor

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	toxicity	toxicity from the extract.
Label and Labeling	Meet FDA's Requirements	Meet FDA's Requirements	SAME

Different Analysis:

The proposed device has conducted the acute systemic toxicity testing, and the test results showed that there was no evidence of systemic toxicity.

8. Summary of Non-Clinical Testing

Bench tests were conducted to verify that the proposed device met all design specifications. The test results demonstrated that the proposed device complies with the following standards:

ASTM D6319-19, Standard Specification for Nitrile Examination Gloves for Medical Application. ASTM D5151-19, Standard Test Method for Detection of Holes in Medical Gloves.

ASTM D6124-17, Standard Test Method for Residual Powder on Medical Gloves.

ISO 10993-10:2010, Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization.

ISO 10993-11:2017 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity

Test Method	Purpose	Acceptance Criteria	Results
ASTM D5151	Testing for Freedomfrom holes	Freedom from holes	Blue Color
	from holes	AQL 2.5	No water leakage is inspected form 200samples
			Purple-Blue Color
			No water leakage is inspected form 200samples
ASTM D6124	Determine the powder	<2.0 mg per glove	Blue Color
	residue for powder free		Residual Powder of Size XS: Average 0.29 mg;
	gloves		Residual Powder of Size S: Average 0.32 mg;
			Residual Powder of Size M: Average 0.39 mg;
			Residual Powder of Size L: Average 0.34 mg;
			Residual Powder of Size XL: Average 0.38mg;
			Purple-Blue Color
			Residual Powder of Size XS: Average 0.33mg;
			Residual Powder of Size S: Average 0.32 mg;
			Residual Powder of Size M: Average 0.32 mg;
			Residual Powder of Size L: Average 0.37 mg;
			Residual Powder of Size XL: Average 0.38mg;
ASTM D412	Testing for Physicalproperty characteristics	Before Aging	Blue Color
ASTM D573	property characteristics	Tensile Strength: 14 MPa min.Ultimate Elongation: 500% min.	Before AgingTensile Strength: ≥ 19 MPa;
ASTM D412ASTM D3767	Testing For physicaldimensions specification	Before AgingTensile Strength: 14 MPa min.Ultimate Elongation: 400% min.	Ultimate Elongation: ≥ 500%.After AgingTensile Strength: ≥ 17.8 MPa;Ultimate Elongation: ≥ 472%.
			Purple-Blue Color
			Before AgingTensile Strength: ≥ 19 MPa;Ultimate Elongation: ≥ 500%.After AgingTensile Strength: ≥ 17.1 MPa;Ultimate Elongation: ≥ 463%.
		Length: 220 mm min. for size (XS, S);Length: 230 mm min. for size (M, L, XL);Width: 70±10 mm for XS; 80±10 mmfor S; 95±10 mm for M; 110±10 mm forL; 120±10 mm for XL.Cuff Thickness: ≥0.05 mm;Finger Thickness: ≥0.05 mm;Palm Thickness: ≥0.05 mm;All acceptance criteria above meet therequirements in Table 1 Dimensions andTolerances of ASTM D6319	Blue ColorLength of Size XS: ≥ 230 mm;Width of Size XS: 75±3 (75-78) mm;Cuff Thickness of Size XS: ≥0.06 mm;Palm Thickness of Size XS: ≥0.07 mm;Finger Thickness of Size XS: ≥0.10 mm.Length of Size S: ≥ 228mm;Width of Size S: 85±2 (85-87) mm;Cuff Thickness of Size S: ≥0.06 mm;Palm Thickness of Size S: ≥0.07 mm;Finger Thickness of Size S: ≥0.10 mm.Length of Size M: ≥ 240 mm;Width of Size M: 95±2 (95-97) mm;Cuff Thickness of Size M: ≥0.06 mm;Palm Thickness of Size M: ≥0.07 mm;Finger Thickness of Size M: ≥0.10 mm.Length of Size L: ≥ 240 mm;Width of Size L: 105±4 (105-109) mm;Cuff Thickness of Size L: ≥0.06 mm;Palm Thickness of Size L: ≥0.07 mm;Finger Thickness of Size L: ≥0.10 mm.Length of Size XL: ≥ 241 mm;Width of Size XL: 115±2 (115-117) mm;Cuff Thickness of Size XL: ≥0.06 mm;Palm Thickness of Size XL: ≥0.07 mm;Finger Thickness of Size XL: ≥0.10 mm

			Purple-Blue Color
			Length of Size XS: ≥ 230 mm;
			Width of Size XS: 75±4 (75-79) mm;
			Cuff Thickness of Size XS: ≥0.05 mm;
			Palm Thickness of Size XS: ≥0.07 mm;
			Finger Thickness of Size XS: ≥0.08 mm.

			Length of Size S: ≥ 235mm;
			Width of Size S: 85±2 (85-87) mm;
			Cuff Thickness of Size S: ≥0.05 mm;
			Palm Thickness of Size S: ≥0.05 mm;
			Finger Thickness of Size S: ≥0.08 mm.

			Length of Size M: ≥ 236 mm;
			Width of Size M: 95±3 (95-98) mm;
			Cuff Thickness of Size M: ≥0.05 mm;
			Palm Thickness of Size M: ≥0.05 mm;
			Finger Thickness of Size M: ≥0.07 mm.

			Length of Size L: ≥ 240 mm;
			Width of Size L: 105±3 (105-108) mm;
			Cuff Thickness of Size L: ≥0.05 mm;
			Palm Thickness of Size L: ≥0.06 mm;
			Finger Thickness of Size L: ≥0.08 mm.

			Length of Size XL: ≥ 240 mm;
			Width of Size XL: 115±3 (116-118) mm;
			Cuff Thickness of Size XL: ≥0.05 mm;
			Palm Thickness of Size XL: ≥0.05 mm;
			Finger Thickness of Size XL: ≥0.08 mm.
ISO 10993-11	Evaluate the endpoint ofSystemic Cytotoxicityfor biocompatibility	The test article showed no evidence ofsystemic toxicity from the extract.	The test article showed no evidence ofsystemic toxicity from the extract.
ISO 10993-10	Evaluate the endpoint ofirritant forbiocompatibility	The response of the test article extract isnegligible.	The test result showed that the response of thetest article extract was categorized asnegligible under the test condition.
	Evaluate the endpoint ofsensitization forbiocompatibility	The test article showed no evidence ofcausing delayed dermal contactsensitization	The test article showed no evidence of causingdelayed dermal contact sensitization in theguinea pig.

Table 5 Performance Test Results Summary

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Summary of Clinical Testing 9. Clinical Testing is not applicable.

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10. Conclusion

Based on the nonclinical tests performed, the subject device is as safe, as effective, and performs as well as the legally marketed predicate device, POWDER FREE Nitrile GLOVES (White, Cobalt Blue, Black, Ice Blue) cleared under K150340.

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.