The Nitrile Examination Golves Powder Free is intended to be worn on the hands of examiners to prevent contamination between patient and examiner. This is a single-use, powder-free, non-sterile device.

Device Description

The subject device is powder free nitrile examination gloves. The subject device is blue. It can be available in four specifications: S,M,L and XL. The subject device is non-sterile.

AI/ML Overview

The provided text describes the acceptance criteria and a study for the "Nitrile Examination Gloves Powder Free" (K212921). This is a physical medical device (gloves), not an AI/ML algorithm or software as a medical device (SaMD). Therefore, many of the requested fields related to AI/ML studies (like effect size of human readers with AI assistance, number of experts for ground truth, adjudication methods, details of training set) are not applicable to this submission.

Here is the information derived from the provided document, with "N/A" for sections not applicable to this physical device:

1. Table of Acceptance Criteria and the Reported Device Performance

Test Method	Purpose	Acceptance Criteria	Reported Device Performance
ASTM D6319	Physical Dimensions Test (Length)	S: ≥220mm; M/L/XL: ≥230mm	Length: > 230mm (Pass)
ASTM D6319	Physical Dimensions Test (Width)	S: 80±10mm; M: 95±10mm; L: 110±10mm; XL: 120±10mm	S: 86-87mm (Pass); M: 97-98mm (Pass); L: 107-108mm (Pass); XL: 115-116mm (Pass)
ASTM D6319	Physical Dimensions Test (Thickness)	Finger: ≥0.05mm; Palm: ≥0.05mm	S: Finger: 0.10-0.11mm (Pass), Palm: 0.06-0.07mm (Pass); M: Finger: 0.11-0.12mm (Pass), Palm: 0.06-0.07mm (Pass); L: Finger: 0.11-0.12mm (Pass), Palm: 0.06-0.07mm (Pass); XL: Finger: 0.11-0.12mm (Pass), Palm: 0.07mm (Pass)
ASTM D5151	Watertightness Test for Detection of Holes	AQL 2.5	0/200 (Pass)
ASTM D6124	Powder Content	< 2.0mg	0.04mg (Pass)
ASTM D412	Physical Properties (Before Aging - Tensile Strength)	≥14MPa	23.3-35.2 (Pass)
ASTM D412	Physical Properties (Before Aging - Ultimate Elongation)	≥500%	496-529 (Pass)
ASTM D412	Physical Properties (After Aging - Tensile Strength)	≥14MPa	20.0-44.5 (Pass)
ASTM D412	Physical Properties (After Aging - Ultimate Elongation)	≥400%	450-500 (Pass)
ISO 10993-11	Cytotoxicity	Non-acute systemic toxicity	Did not show acute systemic toxicity in vivo (Pass)
ISO 10993-10	Irritation	Non-irritating	Not an irritant (Pass)
ISO 10993-10	Sensitization	Non-sensitizing	Not a sensitizer (Pass)

2. Sample size used for the test set and the data provenance

The document provides specific sample sizes for certain tests:

Watertightness Test: 0/200 indicates a sample size of 200 gloves were tested for defects (with 0 failures).
For other tests like dimensions, powder content, and physical properties, specific sample sizes are not explicitly stated in the summary table but are typically defined by the ASTM/ISO standards referenced.
Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective), but it would be from manufacturing lots of the "Jiangsu Standard Health Co.,Ltd" gloves.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

N/A - This is a physical device. Ground truth is established by standardized physical and chemical tests, not expert interpretation of outputs.

4. Adjudication method for the test set

N/A - Adjudication methods like 2+1 or 3+1 are used for expert consensus in clinical or AI studies. For a physical device, compliance is determined by meeting the specified limits of the test standards.

5. 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

N/A - This is not an AI/ML device.

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

N/A - This is not an AI/ML device.

7. The type of ground truth used

The ground truth is based on the physical and chemical properties of the gloves, as measured and evaluated according to internationally recognized ASTM and ISO standards (e.g., ASTM D6319, ASTM D5151, ASTM D6124, ASTM D412, ISO 10993-10, ISO 10993-11, ISO 10993-5).

8. The sample size for the training set

N/A - This concept applies to AI/ML models. For a physical product, there isn't a "training set" in this context. Manufacturing processes are optimized, but this isn't typically referred to as a training set.

9. How the ground truth for the training set was established

N/A - As above, this is not applicable to a physical device in the AI/ML sense.

Summary

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

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.

December 24, 2021

Jiangsu Standard Health Co.,Ltd % Boyle Wang official Correspondent Shanghai Truthful information Technology Co., Ltd. RM. 1801, No. 161 Lujiazui East Rd.,Pudong Shanghai, Shanghai 200120 China

Re: K212921

Trade/Device Name: Nitrile Examination Golves Powder Free Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA Dated: November 15, 2021 Received: November 18, 2021

Dear Boyle 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.

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

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

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, 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

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

Indications for Use

510(k) Number (if known) K212921

Device Name Nitrile Examination Golves Powder Free

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 K212921

This summary of 510(k) is being submitted in accordance with 21 CFR 807.92.

1.0 Submitter's Information

Name: Jiangsu Standard Health Co.,Ltd Address: 19F Fortune Tower, No.1 Wangxi Road, Zhangjiagang City, Jiangsu, China Phone Number: +86-0512-58585333 Contact: Lu Tao Date of Preparation: Sept 6,2021

Designated Submission Correspondent

Mr. Boyle Wang Shanghai Truthful Information Technology Co., Ltd. Room 1801, No. 161 East Lujiazui Rd., Pudong,Shanghai 200120 ,China Tel: +86-21-50313932 Email: Info@truthful.com.cn

2.0 Device Information

Trade name: Nitrile Examination Golves Powder Free Common name: Patient Examination Gloves Classification name: Non-powdered patient examination glove Model(s): S, M, L, XL

3.0 Classification

Production code: LZA Regulation number: 21CFR880.6250 Classification: Class I Panel: General Hospital

4.0 Predicate Device Information

Manufacturer: GUANG DONG KINGFA SCI. & TECH.CO., LTD. Device: Nitrile examination gloves 510(k) number: K203593

5.0 Indication for Use

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

6.0 Device Description

The subject device is powder free nitrile examination gloves. The subject device is blue. It can be available in four specifications: S,M,L and XL. The subject device is non-sterile.

7.0 Technological Characteristic Comparison Table

Item	Subject Device(K212921)	Predicated Device(K203593)	Remark
Product Code	LZA	LZA	Same
Regulation No.	21CFR880.6250	21CFR880.6250	Same
Class	I	I	Same
Intended Use	The Nitrile ExaminationGolves Powder Free isintended to be worn onthe hands of examinersto prevent contaminationbetween patient andexaminer. This is asingle-use, powder-free,non-sterile device.	The nitrile examinationglove is intended to beworn on the hands ofexaminers toprevent contaminationbetween patient andexaminer. This is asingle-use, powder-free,non-sterile device.	Same
Material	Nitrile	Nitrile	Same
Powdered orPowered free	Powdered free	Powdered free	Same
Design Feature	Ambidextrous	Ambidextrous	Same
Colorant	Blue	Blue	Same
LabelingInformation	Single-use indication,powder free, devicecolor, device name,glove size and quantity,Non-Sterile	Single-use indication,powder free, devicecolor, device name,glove size and quantity,Non-Sterile	Same
Dimensions(mm)	Length:S:≥220;M/L/XL: ≥230;Width:S: 80±10;M: 95±10;L: 110±10;	Length:S:≥220;M/L/XL: ≥230;Width:S: 80±10;M: 95±10;L: 110±10;	Same

Table1-General Comparison

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

		XL: 120±10	XL: 120±10
Thickness(mm)		Finger: ≥0.05;Palm: ≥0.05	Finger: ≥0.05;Palm: ≥0.05	Same

PhysicalProperties	BeforeAging	TensileStrength	14MPa,min	TensileStrength	14MPa,min	Same
		UltimateElongation	500% min	UltimateElongation	500% min	Same
	AfterAging	TensileStrength	14MPa,min	TensileStrength	14MPa,min	Same
		UltimateElongation	400%min	UltimateElongation	400%min	Same
Freedom fromHoles		Be free from holes whentested in accordancewith ASTMD5151AQL=2.5		Be free from holes whentested in accordancewith ASTMD5151AQL=2.5		Same
Powder Content		Meet the requirements ofASTM D6124		Meet the requirements ofASTM D6124		Same
Biocompatibility		ISO 10993-10;Under the conditions ofthe study, not an irritantor a sensitizerISO 10993-11;Under thecondition of acutesystemic toxicity test,the test article did notshow acute systemictoxicity in vivo.ISO 10993-5Under conditions of thestudy, device extract iscytotoxic		ISO 10993-10;Under the conditions ofthe study, not an irritantor a sensitizerISO 10993-11;Under thecondition of acutesystemic toxicity test,the test article did notshow acute systemictoxicity in vivo.ISO 10993-5Under conditions of thestudy, device extract iscytotoxic		Same

8.0 Summary of Non-clinical Testing

Non-clinical 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:

ISO 10993-5 Third edition 2009-06-01, Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity.

ISO 10993-10:2010 Biological Evaluation of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization.

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

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

ASTM D6124-06 (Reapproved 2017), Standard Test Method for Residual Powder on Medical Gloves

ASTM D5151-19, Standard Test Method for Detection of Holes in Medical Gloves.

ASTM D6319-19, Standard Specification for Nitrile Examination Gloves for Medical Application.

TestMethod	Purpose	Acceptance Criteria	Results
ASTMD6319	PhysicalDimensionsTest	Length(mm):S:≥220;M/L/XL:≥230;	Length(mm):> 230/Pass;
		Width(mm):S: 80±10;M: 95±10;L: 110±10;XL: 120±10	Width(mm):S: 86-87 /PassM: 97-98/ PassL: 107-108/ PassXL:115-116/ Pass
		Thickness (mm):Finger: ≥0.05Palm: ≥0.05	Thickness (mm):S:Finger: 0.10-0.11/PassPalm: 0.06-0.07/PassM:Finger: 0.11-0.12/PassPalm: 0.06-0.07/PassL:Finger: 0.11-0.12/PassPalm: 0.06-0.07/PassXL:Finger: 0.11-0.12/PassPalm: 0.07/Pass
ASTMD5151	WatertightnessTest forDetection ofHoles	Meet the requirements of ASTM D5151AQL 2.5	0/200/Pass
ASTMD6124	PowderContent	Meet the requirements of ASTM D6124 <2.0mg	0.04mg/Pass;

Table 2 - Summary of non-clinical performance testing

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

ASTMD412	Physicalproperties	BeforeAging	TensileStrength	≥14MPa	23.3-35.2/Pass;
			UltimateElongation	≥500%	496-529/Pass;
		AfterAging	TensileStrength	≥14MPa	20.0-44.5/Pass;
			UltimateElongation	≥400%	450-500/Pass;
ISO10993-11	Cytotoxicity	Non- acute systemictoxicity			Under conditions ofthe study, did notshow acute systemictoxicity in vivo / Pass
ISO10993-10	Irritation	Non-irritating			Under the conditionsof the study, not anirritant/ Pass
ISO10993-10	Sensitization	Non-sensitizing			Under conditions ofthe study, not asensitizer./ Pass

9.0 _Summary of Clinical Testing

Clinical testing is not needed for this device.

10.0 Conclusion

The conclusions drawn from the nonclinical tests demonstrate that the subject device K212921 Nitrile Examination Golves Powder Free is as safe, as effective, and performs as well as or better than the legally marketed predicated device K203593.

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.