A powder free 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. The device is for over-the-counter use.

Device Description

The proposed Nitrile Examination Gloves are ambidextrous, non-sterile, powder-free, Not made with natural rubber latex and is made of nitrile (Butyronitrile latex) . It has a finger textured surface and is colored blue. This is a single use, disposable device(s), provided non-sterile. The device is provided in 4 sizes, from small to extra-large.

AI/ML Overview

The provided text is a 510(k) Summary for Nitrile Examination Gloves (K212929). It does not describe an AI/ML-based medical device. Therefore, it does not contain the information required to answer the prompt regarding acceptance criteria and a study proving an AI/ML device meets those criteria.

The document discusses the following for the Nitrile Examination Gloves:

Acceptance Criteria and Reported Device Performance (Table I and II): These tables detail physical properties (dimensions, tensile strength, elongation), freedom from holes, residual powder, and biocompatibility tests (irritation, sensitization, systemic toxicity, cytotoxicity). The "Reported Device Performance" is the "Proposed Device Nitrile Examination Gloves" column in Table I and the "Results" column in Table II, showing that the product meets or exceeds the specified acceptance criteria for each test.
Study Proving Device Meets Acceptance Criteria: The study proving the device meets the acceptance criteria consists of adherence to established ASTM and ISO standards for examination gloves. These are non-clinical (laboratory) tests.
Sample Size: For the physical dimensions and properties, the sample sizes are not explicitly stated, but the ASTM standards followed would specify these. For "Watertightness Test for Detection of Holes," the result is "0/200/Pass," implying a sample size of 200 gloves tested.
Data Provenance: The data provenance is from laboratory testing performed on the "Proposed Device Nitrile Examination Gloves." The country of origin of the data is not specified, but the manufacturer is WATCHTOWER PPE SUPPLIES, INC. located in Hicksville, New York, USA. The tests are non-clinical, so the concepts of retrospective/prospective clinical data do not apply.
Experts/Ground Truth/Adjudication/MRMC/Standalone: These concepts are relevant to AI/ML device studies where human expert input is used to establish ground truth or evaluate AI performance. They are not applicable to the non-clinical, physical, and biological testing of examination gloves.
Training Set: There is no training set mentioned because this is not an AI/ML device.

In summary, the provided document describes the regulatory clearance for a physical medical device (nitrile examination gloves) based on non-clinical performance and biocompatibility testing against established standards, not an AI/ML device.

Summary

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

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. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

April 9, 2022

Watchtower PPE Supplies Inc. % Rafi Wong Manager Pacific Fortune Management Inc. 2350 Mission College Blvd. Ste 475 Santa Clara, California 95054

Re: K212929

Trade/Device Name: Nitrile Examination Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA Dated: March 15, 2022 Received: March 16, 2022

Dear Rafi Wong:

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,

Bifeng Qian, M.D., Ph.D. Acting 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}------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K212929

Device Name Nitrile Examination Gloves

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}------------------------------------------------

510K SUMMARY K212929

Date of Summary Prepared: March 15, 2022

510K Number: K212929

1. Submitter Information

Submitter Contact:

Address:

WATCHTOWER PPE SUPPLIES, INC. 600 W John Street, Ste 140B, Hicksville, New York 11801, USA

Submitter Contact Person:

Name:	Riva Zheng
Phone Number:	(+1)646-717-6266
Email:	watchtowersupplies@gmail.com

	Designated Submission Correspondent:

Name:	Rafi Wong
Phone Number:	+1 (408) 646-6537
Email:	rafi.wong@pfmfinance.com

1. Device Name: Nitrile Examination Gloves

3. Regulatory Information

Common Name:	Polymer Patient Examination Glove
Apparel Classification:	Class I
Product Code:	LZA
Regulation Number:	21 CFR 880.6250

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

4. Predicate Device

510K Number:	K192333
Company name:	JR Engineering & Medical Technologies (M) SDN.BHD.
Device Name:	Blue Nitrile Examination Gloves Powder Free
Cleared date:	January 24, 2020

5. Intended Use/Indications for Use

Device Description 6.

7. Summary of Comparison and Technological Characteristics

Characteristics	AcceptanceCriteria	Proposed DeviceNitrileExaminationGloves	Predicate DeviceBlue NitrileExaminationGloves PowderFree	Comparison
510K Number	/	K212929	K192333	-
Product Code	LZA	LZA	LZA	Same
Manufacturer	/	WATCHTOWERPPE SUPPLIES,INC.	JR Engineering &MedicalTechnologies (M)SDN.BHD.	Different
Classification	Class I (21 CFR880.6250)	Class I (21 CFR880.6250)	Class I (21 CFR880.6250)	Same

Intended Use /Indications for Use	A patientexaminationglove is adisposabledevice intendedfor medicalpurposes that isworn on theexaminer's handsor fingers topreventcontaminationbetween patientand examiner.The device is forover- the-counteruse.	A powder freepatientexaminationglove is adisposable deviceintended formedical purposesthat is worn onthe examiner'shand or finger topreventcontaminationbetween patientand examiner.The device is forover-the-counteruse.	A powder freepatient examinationgloves is adisposable deviceintended formedical purposesthat is worn on theexaminer's hand orfinger to preventcontaminationbetween patient andexaminer.	Same
Material Use	Nitrile	Nitrile	Nitrile	Same
Color	Blue	Blue	Blue	Same
Sterility	Non-sterile	Non-sterile	Non-sterile	Same
Dimensions(ASTMD6319- 19)	OverallLength(mm) 220mm = (sizesXS-S)230 mm =(sizes M-XL)Width (±10mm) Size S =80 mm SizeM = 95 mmSize L = 110mm Size XL= 120 mmThickness atFinger(mm)All Sizes =0.05mmThickness atPalm(mm)	Size: MLength Min:230mm PalmWidth Min: 95+/-10mmFingerThickness min:0.05 mm PalmThicknessmin: 0.05 mm	Size: MLengthMin:230mmPalm Width Min:95+/-10mmFinger Thicknessmin: 0.05 mmPalm Thicknessmin: 0.05 mm	Same
	All Sizes =0.05mm
	Before Aging ASTM D6319-19
PhysicalProperties	TensileStrength(MPa) = 14min.	Tensile Strength(Mpa)$≥$ 14 min.	Tensile Strength(Mpa) = 14 min.	Same
	UltimateElongation(%) = 500min.	UltimateElongation(%) 500 min.	UltimateElongation (%)= 500 min.	Same
	After Aging ASTM D6319-19
	TensileStrength(Mpa) = 14min.	Tensile Strength(Mpa)$≥$ 14 min.	TensileStrength (Mpa)$≥$ 14 min.	Same
	UltimateElongation(%) = 400min.	UltimateElongation(%) 400 min.	UltimateElongation(%) 400 min.	Same
Freedom fromHoles(ASTM D5151)	AQL 2.5InspectionLevel G-1	Passes AQL-2.5	Passes AQL-2.5	Same
ResidualPower (ASTMD6124)	$≤$ 2.0 mg/pc	$≤$ 2.0 mg/pc	$≤$ 2.0 mg/pc	Same
	Primary SkinIrritation TestISO 10993-10	Under theconditions ofstudy, the testarticle showed noirritationon the skin.	Under the conditionof study not anirritant.	Same
Biocompatibility	DermalSensitizationAssayISO 10993-10	Under theconditions ofstudy, there is noevidence that thetest articleextracts wouldcausesensitization onguinea pig.	Under theconditions of thestudy not asensitizer.	Same
	In VitroCytotoxicityISO 10993-5	Under theconditions of thisstudy,the MEMtest extractswould beconsideredcytotoxicpotential.	Under theconditions of thestudy, cytotoxic.Additional testingwas performed todetermine if thiswas a systemictoxicity concern.	Same
	AcuteSystemicCytotoxicityISO10993-11	Under theconditions of thisstudy, there is nomortality orevidence ofsystemic toxicityfrom the extracts.The test met thetest requirements.	Under the conditionof the study thedevice extracts donot pose a systemictoxicity concern.	Same
	MaterialMediatedPyrogenicityISO 10993-11	Under theconditions of thisstudy, the testarticle would beconsidered nofebrile reaction.The test articlemeets the testrequirements.	Not performed	N/A

Table I - General Comparison

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

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

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

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

8. Non-clinical Tests Performed on the Proposed Device

The proposed device was tested and conformed to the following standards and the requirements stated in the Guidance for Industry and FDA Staff: Medical Glove Guidance Manual Document, issued on January 22, 2008

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 D6124-06/(R)2017 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
ISO 10993- 1: 2009/(R)2013 Biological Evaluation of Medical Devices- Part 1: Evaluation . and testing within a risk management process
. ISO 10993-2:2006/(R)2014 Biological Evaluation of medical devices - Part 2: Animal welfare requirements
. ISO 10993-12:2012 Biological evaluation of medical devices - Part 12: Sample preparation and reference materials

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

Test Method	Purpose	Acceptance Criteria	Results
ASTM D6319-19	PhysicalDimensionsTest	Length(mm):S:≥220;M/L/XL:≥230;Width(mm):S: 80±10;M: 95±10;L: 110±10;XL: 120±10Thickness (mm):Finger: ≥0.05Palm: ≥0.05	Length(mm): >240/Pass;Width(mm):S: 87-88/PassM: 96-97/ PassL: 110/ Pass;XL:114-115/ PassThickness (mm):S:Finger: 0.115-0.123/PassPalm: 0.066-0.073/PassM:Finger: 0.120-0.132/PassPalm: 0.067-0.075/PassL:Finger: 0.118-0.125/PassPalm: 0.069-0.073/PassXL:Finger: 0.113-0.120/PassPalm: 0.068-0.072/Pass

	Physical properties	BeforeAging	TensileStrength	≥14MPa	30.7-38 MPa/Pass
		BeforeAging	UltimateElongation	≥500%	500-525%/Pass
		AfterAging	TensileStrength	≥14MPa	22.4-41 MPa/Pass
		AfterAging	UltimateElongation	≥400%	457-516%/Pass

Table II. Summary of Non-Clinical Performance Testing

{10}------------------------------------------------

ASTM D5151-19	WatertightnessTest for Detectionof Holes	Meet the requirements ofASTM D5151AQL 2.5	0/200/Pass
ASTM D6124-06/(R)2017	Powder Content	Meet the requirements ofASTM D6124 < 2.0mg	0.1mg/Pass;
ISO 10993-10:2010	Irritation	Non-irritating	Under the conditions of the study,not anirritant/ Pass
ISO 10993-10	Sensitization	Non-sensitizing	Under conditions of the study,not a sensitizer./ Pass
ISO 10993-11	To evaluate thepotential formedical devicematerials to causeadverse systemicreactions	Non- systemictoxicity	Under conditions of the study,There was no evidence of systemictoxicity from the extract / Pass
ISO 10993-5	This part of ISO10993 describestest methods toassess the in vitrocytotoxicity ofmedical devices.	The viab.% of the100% extract of thetest article is the finalresult, and if viability isreduced to <70% ofthe blank, it hascytotoxic potential	Viab.% of 100% test article extractis 9.87%It means the proposed device havepotential toxicity to L-929 in theMTT method/ Pass

{11}------------------------------------------------

9. Clinical Test

There is no clinical study included in this submission.

10. Conclusion

The conclusions drawn from the non-clinical tests demonstrate that the proposed device Nitrile Examination Gloves are as safe, as effective, and performs as well as or better than the predicate device, Blue Nitrile Examination Gloves Powder Free (K192333) manufactured by JR Engineering & Medical Technologies (M) SDN.BHD.

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.