The 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, 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 provided non-sterile. The proposed device is made of Nitrile.

AI/ML Overview

The provided text describes the acceptance criteria and the study results for "Nitrile Examination Gloves (Powder free, Blue)". This is a physical medical device, not a software-driven AI device. Therefore, the specific questions regarding AI-related performance metrics (like sample size for test set/training set, data provenance, number of experts for ground truth, adjudication method, MRMC studies, standalone algorithm performance) are not applicable to this document.

However, I can extract the acceptance criteria and reported device performance from the provided tables.

Acceptance Criteria and Reported Device Performance

Test Method	Purpose	Acceptance Criteria	Reported Device Performance	Comments
Physical Performance (ASTM D6319, D412, D573)
Freedom from Holes (ASTM D5151)	Testing for Freedom from holes	AQL 2.5	No water leakage is inspected from 200 samples	Meets acceptance criteria.
Residual Powder (ASTM D6124)	Determine the powder residue for powder free gloves	< 2.0 mg per glove	Size XS: Average 0.28 mg; Size S: Average 0.31 mg; Size M: Average 0.34 mg; Size L: Average 0.31 mg; Size XL: Average 0.40mg	Meets acceptance criteria.
Tensile Strength (Before Aging)	Physical property characteristics	14 MPa min.	≥ 19MPa	Meets acceptance criteria.
Ultimate Elongation (Before Aging)	Physical property characteristics	500% min.	≥ 500%.	Meets acceptance criteria.
Tensile Strength (After Aging)	Physical property characteristics	14 MPa min.	≥ 18 MPa	Meets acceptance criteria.
Ultimate Elongation (After Aging)	Physical property characteristics	400% min.	≥ 473%.	Meets acceptance criteria.
Physical Dimensions (ASTM D412, D3767)
Length (XS, S)	Physical dimensions specification	220 mm min.	Size XS: ≥ 223 mm; Size S: ≥ 224 mm	Meets acceptance criteria.
Length (M)	Physical dimensions specification	230 mm min.	Size M: ≥ 233 mm	Meets acceptance criteria.
Length (L, XL)	Physical dimensions specification	235 mm min.	Size L: ≥ 236 mm; Size XL: ≥ 236 mm	Meets acceptance criteria.
Width (XS)	Physical dimensions specification	70 ± 10 mm	75 ± 2 (73-77) mm	Meets acceptance criteria.
Width (S)	Physical dimensions specification	80 ± 10 mm	85 ± 2 (85-87) mm	Meets acceptance criteria.
Width (M)	Physical dimensions specification	95 ± 10 mm	95 ± 3 (95-98) mm	Meets acceptance criteria.
Width (L)	Physical dimensions specification	110 ± 10 mm	115 ± 4 (115-119) mm	Meets acceptance criteria.
Width (XL)	Physical dimensions specification	120 ± 10 mm	125 ± 2 (115-117) mm	Meets acceptance criteria.
Cuff Thickness	Physical dimensions specification	≥ 0.05 mm	Size XS, S, M, L, XL: ≥ 0.06 mm	Meets acceptance criteria.
Palm Thickness	Physical dimensions specification	≥ 0.05 mm	Size XS, S, M, L, XL: ≥ 0.07 mm	Meets acceptance criteria.
Finger Thickness	Physical dimensions specification	≥ 0.05 mm	Size XS, S, M, L, XL: ≥ 0.10 mm	Meets acceptance criteria.
Biocompatibility (ISO 10993-5, ISO 10993-10)
Cytotoxicity (ISO 10993-5)	Evaluate the endpoint of Cytotoxicity for biocompatibility	No evidence of cytotoxic potential from the extract.	No evidence of systemic toxicity from the extract.	Meets acceptance criteria.
Irritation (ISO 10993-10)	Evaluate the endpoint of irritant for biocompatibility	No irritation on the skin.	No irritation on the skin.	Meets acceptance criteria.
Sensitization (ISO 10993-10)	Evaluate the endpoint of sensitization for biocompatibility	No evidence of causing delayed dermal contact sensitization.	No evidence of causing delayed dermal contact sensitization in the guinea pig.	Meets acceptance criteria.

Study Information (where applicable based on the provided document):

Sample size used for the test set and the data provenance:
- Freedom from Holes (ASTM D5151): 200 samples were inspected.
- Biocompatibility (ISO 10993-10 for sensitization): Guinea pig was used for sensitization test. The document does not specify the exact number of guinea pigs.
- Data Provenance: The document does not explicitly state the country of origin where the tests were performed or if they were retrospective or prospective studies. The company is based in China.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. These are physical and chemical bench tests, not involving expert interpretation of data for ground truth.
Adjudication method for the test set: Not applicable.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable, as this is a physical device, not an AI or imaging device involving human readers.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable, as this is a physical device.
The type of ground truth used: For physical and chemical tests, the "ground truth" is defined by the technical specifications outlined in the referenced ASTM and ISO standards (e.g., specific tensile strength values, elongation percentages, powder residue limits for ASTM standards, and bio-response criteria for ISO biocompatibility standards).
The sample size for the training set: Not applicable, as this is a physical device.
How the ground truth for the training set was established: Not applicable.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & 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.

December 14, 2021

Weihai Hongyu Nonwoven Fabric Products 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: K213029

Trade/Device Name: 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 21, 2021 Received: September 21, 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 (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 mediation-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, PhD Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K213029

Device Name

Nitrile Examination Gloves (Powder free, Blue)

Indications for Use (Describe)

The 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.

Type of Use (Select one or both, as applicable)
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__ Prescription Use (Part 21 CFR 801 Subpart D)

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

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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: K213029

1. Date of Preparation: 11/23/2021
1. Sponsor

Weihai Hongyu Nonwoven Fabric Products Co., Ltd.

No.567, Gushan Road, Area of Economy and Technique,264207, Weihai City, Shandong Province, P.R. China. Contact Person: Dong Bin Position: General Manager Tel: +86-15662383633 Fax: +86-631-3636942 Email: dbfeel@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: information@believe-med.com

Proposed Device Identification 4.
Trade Name: 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

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Review Panel: General Hospital

Indication For Use Statement:

The 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.

Predicate Device Identification 5.
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, 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 provided non-sterile. The proposed device is made of Nitrile.

Designation	Size					Tolerance
	XS	S	M	L	XL
Length, mm	220	220	230	235	235	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

Table 2 Performance and Physical Specifications
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Before Aging		After Aging		Pinhole AQL
TensileStrength	UltimateElongation	TensileStrength	UltimateElongation	2.5
14 MPa, min	500 % min	14 MPa, min	400 % min

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

Comparison of Technological Characteristics 7.

ITEM	Proposed Device(K213029)	Predicate Device (K150340)	Remark
	Nitrile Examination Gloves (Powder free,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
Class	I	I	SAME
Intended Use	The Nitrile Examination Gloves (Powderfree, Blue) is a disposable device intendedfor medical 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

Table 1 General Comparison

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Proposed Device(K213029)		Size
Nitrile Examination Gloves(Powder free, Blue)		Designation	XS	S	M	L	XL	Tolerance
		Length, mm	220	220	230	235	235	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.

So we consider this as the proposed device is similar to the predicate device.

ITEM	Proposed Device(K213029)Nitrile Examination Gloves(Powder free, Blue)	Predicate Device (K150340)POWDER FREE Nitrile GLOVES(White, Cobalt Blue, Black, IceBlue)	Remark
Colorant	Blue	White, Cobalt Blue, Black, Ice Blue	Different
Single Use	Yes	Yes	SAME
PhysicalProperties	BeforeAging	Tensile Strength	14 MPa, min	15 MPa, min	Different
	UltimateElongation	500 % min	500 % min	SAME
	AfterAging	TensileStrength	14 MPa, min	14 MPa, min	SAME

Table 3 Performance Comparison

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	UltimateElongation	400 % min	400 % min
	Comply with ASTM D6319	Comply with ASTM D6319	SAME
Freedom from Holes	Be free from holes when tested inaccordance with ASTM D5151,AQL 2.5	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 10993-5, and ISO 10993-10 the test results showed that the proposed devices with blue colorant did not induce skin irritation and showed no significant evidence of causing skin sensitization and no cytotoxic potential.

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 (K213029)Nitrile Examination Gloves(Powder free, Blue)	Predicate Device (K150340)POWDER FREE Nitrile GLOVES(White, Cobalt Blue, Black, IceBlue)	Remark
Material		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.	SAME
	Cytotoxic	Under the conditions of the study,there was no evidence of cytotoxicpotential from the extract.	Not Available	Different
Label and Labeling		Meet FDA's Requirements	Meet FDA's Requirements	SAME

Table 4 Safety Comparison

Different Analysis:

The proposed device has conducted the acute cytotoxic testing, and the test results shown that there was

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no evidence of cytotoxic potential.

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 10993-5:2009, Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity.

Test Method	Purpose	Acceptance Criteria	Results
ASTM D5151	Testing for Freedomfrom holes	Freedom from holesAQL 2.5	No water leakage is inspected form 200 samples
ASTM D6124	Determine the powderresidue for powder freegloves	<2.0 mg per glove	Residual Powder of Size XS: Average 0.28 mg;
			Residual Powder of Size S: Average 0.31 mg;
			Residual Powder of Size M: Average 0.34 mg;
			Residual Powder of Size L: Average 0.31 mg;
			Residual Powder of Size XL: Average 0.40mg;
ASTM D412ASTM D573	Testing for Physicalproperty characteristics	Before AgingTensile Strength: 14 MPa min.Ultimate Elongation: 500% min.	Before AgingTensile Strength: ≥ 19MPa;Ultimate Elongation: ≥ 500%.
		Before AgingTensile Strength: 14 MPa min.Ultimate Elongation: 400% min.	After AgingTensile Strength: ≥ 18 MPa;Ultimate Elongation: ≥ 473%.
ASTM D412ASTM D3767	Testing For physicaldimensions specification	Length: 220 mm min. for size (XS, S);Length: 230 mm min. for size (M);Length: 235 mm min. for size (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	Length of Size XS: ≥ 223 mm;Width of Size XS: 75±2 (73-77) 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: ≥ 224mm;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: ≥ 233 mm;

Table 5 Performance Test Results Summary

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			Width of Size M: 95±3 (95-98) 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: ≥ 236mm;
			Width of Size L: 115±4 (115-119) 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: ≥ 236 mm;
			Width of Size XL: 125±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.

ISO 10993-5	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 test article showed no irritation onthe skin.	The test article showed no irritation on theskin.
	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.

9. 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.