The DISPOSABLE NITRILE EXAMINATION GLOVES (Powder free, 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, 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. The color of the proposed device is Blue.

The proposed device is not provided as sterilized The proposed device is made of Nitrile.

AI/ML Overview

This document is a 510(k) Summary for a medical device called "DISPOSABLE NITRILE EXAMINATION GLOVES (Powder free, Blue)". It is an FDA submission to demonstrate substantial equivalence to a legally marketed predicate device.

The section providing acceptance criteria and performance data is "Table 5 Performance Test Results Summary" on pages 8-10.

Here's the breakdown of the information requested:

1. Table of Acceptance Criteria and Reported Device Performance

Test Method	Purpose	Acceptance Criteria	Reported Device Performance
ASTM D5151	Testing for Freedom from holes	Freedom from holes AQL 2.5	No water leakage inspected from 200 samples (This implies meeting or exceeding the AQL 2.5, as no holes were found).
ASTM D6124	Determine the powder residue for powder free gloves	< 2.0 mg per glove	Residual Powder: Size S: Average 0.36 mg; Size M: Average 0.37 mg; Size L: Average 0.34 mg; Size XL: Average 0.32 mg.
ASTM D412, ASTM D573	Testing for Physical property characteristics (Tensile Strength & Ultimate Elongation)	Before Aging: Tensile Strength: 14 MPa min.; Ultimate Elongation: 500% min.After Aging: Tensile Strength: 14 MPa min.; Ultimate Elongation: 400% min.	Before Aging: Tensile Strength: ≥ 19MPa; Ultimate Elongation: ≥ 500%.After Aging: Tensile Strength: ≥ 18 MPa; Ultimate Elongation: ≥ 472%.
ASTM D412, ASTM D3767	Testing For physical dimensions specification	Length: 220 mm min. for S; 230 mm min. for M, L, XL.Width: 80±10 mm for S; 95±10 mm for M; 110±10 mm for L; 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 the requirements in Table 1 Dimensions and Tolerances of ASTM D6319.	Size S: Length: ≥ 223mm; Width: 85±2 (85-87) mm; Cuff Thickness: ≥ 0.06 mm; Palm Thickness: ≥ 0.07 mm; Finger Thickness: ≥ 0.10 mm.Size M: Length: ≥ 231 mm; Width: 95±3 (95-97) mm; Cuff Thickness: ≥ 0.06 mm; Palm Thickness: ≥ 0.07 mm; Finger Thickness: ≥ 0.10 mm.Size L: Length: ≥ 231mm; Width: 107±2 (105-109) mm; Cuff Thickness: ≥ 0.06 mm; Palm Thickness: ≥ 0.07 mm; Finger Thickness: ≥ 0.10 mm.Size XL: Length: ≥ 233mm; Width: 121±6 (115-127) mm; Cuff Thickness: ≥ 0.06 mm; Palm Thickness: ≥ 0.07 mm; Finger Thickness: ≥ 0.10 mm.
ISO 10993-11	Evaluate the endpoint of Cytotoxicity for biocompatibility	The test article showed no evidence of cytotoxic potential from the extract.	The test article showed no evidence of systemic toxicity from the extract. (This appears to be a slight mismatch in the reported "Purpose" and "Results" cell content for ISO 10993-11, possibly an error in the document, as cytotoxicity and systemic toxicity are distinct endpoints. However, the result for systemic toxicity is provided.)
ISO 10993-10	Evaluate the endpoint of irritant for 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	Evaluate the endpoint of sensitization for biocompatibility	The test article showed 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 (from "No water leakage is inspected form 200 samples").
- Other physical/performance tests (Tensile Strength, Elongation, Dimensions, Powder Residue): Not explicitly stated, but typically these tests use statistical sampling plans from the respective ASTM standards. For example, ASTM D6319 often references sampling procedures. The reported values are averages, implying multiple samples were tested for each size.
Sample Size for Biocompatibility Tests (ISO 10993-series): Not explicitly stated, but standard protocols for these tests typically involve a specific number of animals/samples per test.
Data Provenance: Not explicitly stated regarding country of origin or retrospective/prospective nature. However, the sponsor and submission correspondent are based in China, suggesting the testing was likely conducted there or overseen by labs affiliated with the manufacturer. The tests are bench tests ("Summary of Non-Clinical Testing"), so they are experimental in nature, not retrospective or prospective clinical data.

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

This document describes performance testing of a physical medical device (examination gloves) against established ASTM and ISO standards. It does not involve human interpretation of medical images or diagnoses that would require expert "ground truth" establishment in the way AI/ML devices do. Therefore, this section is not applicable for this type of device and testing. The "ground truth" here is the objective measurement against the specified standard criteria.

4. Adjudication Method for the Test Set

Not applicable. This is not a study involving subjective human assessment or consensus on, for example, diagnostic findings. The tests involve objective measurements and established physical/chemical testing protocols.

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

No. This is a 510(k) submission for examination gloves, which are Class I devices. It's a non-clinical bench test report to demonstrate substantial equivalence based on physical and safety characteristics. MRMC studies are typically performed for AI/ML-enabled diagnostic devices where human reader performance is a critical factor.

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

Not applicable. This device is a physical product (gloves), not an algorithm or AI/ML software.

7. The Type of Ground Truth Used

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

Standard Specifications: Requirements outlined in ASTM D6319-19, ASTM D5151-19, ASTM D6124-17 (for physical performance and holes).
Biocompatibility Standards: ISO 10993-10:2010 and ISO 10993-11:2017 (for irritation, sensitization, and systemic toxicity).

These are objective, measurable criteria established by recognized national and international standards bodies.

8. The Sample Size for the Training Set

Not applicable. This device is a manufactured product, not a software algorithm that requires a "training set" in the machine learning sense. The manufacturer's production processes are subject to Good Manufacturing Practices (GMP) and Quality System (QS) regulations, which ensure consistent product quality, but this isn't a "training set" like in AI/ML.

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

Not applicable, as there is no "training set" in the context of this device. The manufacturing process is controlled by quality systems rather than data-driven machine learning training.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows 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. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

October 28, 2021

Leping Shengde Medical Technology Company Limited % 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: K211581

Trade/Device Name: Disposable Nitrile Examination Gloves (Powder free, Blue) Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA Dated: September 30, 2021 Received: October 6, 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.

{1}------------------------------------------------

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

{2}------------------------------------------------

Indications for Use

510(k) Number (if known)

K211581

Device Name

DISPOSABLE NITRILE EXAMINATION GLOVES (Powder free, Blue)

Indications for Use (Describe)

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."

{3}------------------------------------------------

510(k) Summary

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: K211581

1. Date of Preparation: 10/28/2021
1. Sponsor

LEPING SHENGDE MEDICAL TECHNOLOGY COMPANY LIMITED

No.17, Yubao Village, Lingang Village Committee, Lingang Town, Leping City, Jingdezhen City, Jiangxi Province, China, 333300 Contact Person: Sheng Jianchao Position: General Manager Tel: +86-18925274085 Fax: +86-798-6688879 Email: 18925274085@163.com

1. Submission Correspondent

Beijing Believe-Med Technology Service Co., Ltd.

Rm.912, Building #15, XiYueHui, No.5, YiHe North Rd., FangShan District, Beijing, China,102401 Contact Person: Ray Wang Position: General Manager 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, 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

{4}------------------------------------------------

Indication For Use Statement:

Predicate Device Identification 5.
Primary Predicate Device 510(k) Number: K150340 Product Name: POWDER FREE Nitrile GLOVES (White, Cobalt Blue, Black, Ice Blue) Manufacturer: HEBEI HONGSEN PLASTICS TECHNOLOGY CO., LTD

Reference Device 510(k) Number: K210898 Product Name: Disposable Nitrile Examination Gloves (Powder free, Purple-Blue, Blue) Manufacturer: Tangshan Lanhai Medical Supplies Co., Ltd.

1. Device Description
  The proposed device, DISPOSABLE NITRILE EXAMINATION GLOVES (Powder free, 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. The color of the proposed device is Blue.

The proposed device is not provided as sterilized The proposed device is made of Nitrile.

Table 1 Device Size Specifications
SizeModel	CuffThickness(mm)	PalmThickness(mm)	FingerThickness(mm)	Width(mm)	Length(mm)	Color
S	$\ge 0.05$	$\ge 0.05$	$\ge 0.05$	80±10	$\ge 220$
M	$\ge 0.05$	$\ge 0.05$	$\ge 0.05$	95±10		Blue
L	$\ge 0.05$	$\ge 0.05$	$\ge 0.05$	110±10	$\ge 230$
XL	$\ge 0.05$	$\ge 0.05$	$\ge 0.05$	120±10

T.1.1. 1 D .. ત:

Table 2 Performance and Physical Specifications

Before Aging		After Aging		Pinhole AQL
Tensile	Ultimate	Tensile	Ultimate	1.5

{5}------------------------------------------------

Strength	Elongation	Strength	Elongation
14 MPa, min	500 % min	14 MPa, min	400 % min

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

Table 1 General Comparison

	Proposed Device	Predicate Device (K150340)
ITEM	DISPOSABLE NITRILE EXAMINATIONGLOVES (Powder free, Blue)	POWDER FREE Nitrile GLOVES (White,Cobalt Blue, Black, Ice Blue)	Remark
Product Code	LZA	LZA	SAME
Regulation No.	21 CFR 880.6250	21 CFR 880.6250	SAME
Class	I	I	SAME
Intended Use	The DISPOSABLE NITRILEEXAMINATION GLOVES (Powder free,Blue) is a disposable device intended formedical purposes that is worn on theexaminer's hands to prevent contaminationbetween patient 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

{6}------------------------------------------------

Proposed Device	Designation	Size				Tolerance
DISPOSABLE NITRILEEXAMINATION GLOVES(Powder free, Blue)	Length, mm	S	M	L	XL	min
	Width, mm	80	95	110	120	±10
Thickness, mm:
	Finger	0.05				min
	Palm	0.05				min
	Cuff	0.05				min
Predicate Device (K150340)	Designation	Size					Tolerance
POWDER FREE NitrileGLOVES (White, Cobalt Blue,Black, Ice Blue)	Length, mm	XS	S	M	L	XL	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
Reference Device	Designation	Size				Tolerance
DISPOSABLE NITRILEEXAMINATION GLOVES(Powder free, Blue)	Length, mm	S	M	L	XL	min
	Width, mm	80	95	110	120	±10
Thickness, mm:
	Finger	0.05				min
	Palm	0.05				min
	Cuff	0.05				min
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	Predicate Device (K150340)	Reference Device (K210898)	Remark
ITEM	DISPOSABLE NITRILEEXAMINATION GLOVES(Powder free, Blue)	POWDER FREE NitrileGLOVES (White, CobaltBlue, Black, Ice Blue)	DISPOSABLE NITRILEEXAMINATION	Remark

Table 3 Performance Comparison

{7}------------------------------------------------

					GLOVES (Powder free,Blue)
					Purple-Blue, Blue	Different
PhysicalProperties	Colorant		Blue	White, Cobalt Blue, Black,Ice Blue
	BeforeAging	TensileStrength	14 MPa, min	15 MPa, min	14 MPa, min	Different
		UltimateElongation	500 % min	500 % min	500% min	SAME

	AfterAging	TensileStrength	14 MPa, min	14 MPa, min	14 MPa min	SAME
		UltimateElongation	400 % min	400 % min	400% min	SAME

				Comply with ASTM D6319	Comply with ASTM D6319	Comply with ASTMD6319

Freedom from Holes			Be free from holes when testedin accordance with ASTMD5151AQL 1.5	Be free from holes whentested in accordance withASTM D5151AQL 1.5	Be free from holes whentested in accordance withASTM D5151AQL 2.5	SAME
Powder Content			Less than 2 mg per glove whentested in accordance with ASTMD6124	Meet the requirements ofASTM 6124	Meet the requirements ofASTM 6124	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.

Table 4 Safety Comparison

ITEM		Proposed Device	Predicate Device (K150340)	Reference Device(K210898)	Remark
Material		Nitrile	Nitrile	Nitrile	SAME
Biocompatibility	Irritation	Under the conditions of thestudy, not an irritant	Under the conditions of thestudy, not an irritant	Under the conditions of thestudy, not an irritant	SAME
	Sensitization	Under conditions of the	Under conditions of the study,	Under conditions of the
		DISPOSABLE NITRILEEXAMINATION GLOVES(Powder free, Blue)	POWDER FREE NitrileGLOVES (White, CobaltBlue, Black, Ice Blue)	DISPOSABLE NITRILEEXAMINATIONGLOVES (Powder free,Blue)

{8}------------------------------------------------

		study, not a sensitizer.	not a sensitizer.	study, not a sensitizer.
	acutesystemictoxicity	Under the conditions of thestudy,there was no evidence ofsystemic toxicity from theextract.	Not Available	Under the conditions of thestudy,there was no evidence ofsystemic toxicity from theextract.	Different
Label and Labeling		Meet FDA's Requirements	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.

Summary of Non-Clinical Testing 8.
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 Freedom from holes	Freedom from holesAQL 2.5	No water leakage is inspected form 200 samples
ASTM D6124	Determine the powder residue for powder free gloves	<2.0 mg per glove	Residual Powder of Size S: Average 0.36 mg;Residual Powder of Size M: Average 0.37 mg;Residual Powder of Size L: Average 0.34 mg;Residual Powder of Size XL: Average 0.32mg;
ASTM D412ASTM D573	Testing for Physical property characteristics	Before AgingTensile Strength: 14 MPa min.Ultimate Elongation: 500% min.Before AgingTensile Strength: 14 MPa min.Ultimate Elongation: 400% min.	Before AgingTensile Strength: $\ge$ 19MPa;Ultimate Elongation: $\ge$ 500%.After AgingTensile Strength: $\ge$ 18 MPa;Ultimate Elongation: $\ge$ 472%.
ASTM D412ASTM D3767	Testing For physical dimensions specification	Length: 220 mm min. for size (S);Length: 230 mm min. for size (M, L, XL);80±10 mm for S; 95±10 mm for M;	Length of Size S: $\ge$ 223mm;Width of Size S: 85±2 (85-87) mm;Cuff Thickness of Size S: $\ge$ 0.06 mm;Palm Thickness of Size S: $\ge$ 0.07 mm;

Table 5 Performance Test Results Summary

{9}------------------------------------------------

		110 $\pm$ 10 mm for L; 120 $\pm$ 10 mm for XL.	Finger Thickness of Size S: $\geq$ 0.10 mm.
		Cuff Thickness: $\geq$ 0.05 mm;
		Finger Thickness: $\geq$ 0.05 mm;	Length of Size M: $\geq$ 231 mm;
		Palm Thickness: $\geq$ 0.05 mm;	Width of Size M: 95 $\pm$ 3 (95-97) mm;
		All acceptance criteria above meet the	Cuff Thickness of Size M: $\geq$ 0.06 mm;
		requirements in Table 1 Dimensions and	Palm Thickness of Size M: $\geq$ 0.07 mm;
		Tolerances of ASTM D6319	Finger Thickness of Size M: $\geq$ 0.10 mm.
			Length of Size L: $\geq$ 231mm;
			Width of Size L: 107 $\pm$ 2 (105-109) mm;
			Cuff Thickness of Size L: $\geq$ 0.06 mm;
			Palm Thickness of Size L: $\geq$ 0.07 mm;
			Finger Thickness of Size L: $\geq$ 0.10 mm.


			Length of Size XL: $\geq$ 233mm;
			Width of Size XL: 121 $\pm$ 6 (115-127) mm;
			Cuff Thickness of Size XL: $\geq$ 0.06 mm;
			Palm Thickness of Size XL: $\geq$ 0.07 mm;
			Finger Thickness of Size XL: $\geq$ 0.10 mm.

ISO 10993-11	Evaluate the endpoint ofCytotoxicity forbiocompatibility	The test article showed no evidence ofcytotoxic potential 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.

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

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.