The Patient Examination Gloves are disposable devices intended for medical purposes that are worn on the examiner's hands to prevent contamination between patient and examiner.

Device Description

The proposed device is a nitrile patient examination glove. The design of proposed device addresses the standard specification requirements of ASTM D6319-19. The proposed device is non-sterile and powder free, with fern green, midnight black and sky blue three colors.

AI/ML Overview

The document provided describes the acceptance criteria and the results of non-clinical performance testing for "Patient Examination Gloves" (nitrile gloves) in support of a 510(k) submission (K230777).

Here's an analysis of the provided information, focusing on the requested aspects.

1. A table of acceptance criteria and the reported device performance

Please note that for multiple colors of gloves (Fern Green, Blue Sky, Midnight Black), the results were consistently reported and are summarized below for brevity where they pass the criteria. Where specific values for each color are provided and vary, they are listed.

Acceptance Criteria and Reported Device Performance

No.	Name of the Test Methodology	Standard	Acceptance Criteria	Reported Device Performance and Remarks	Pass/Fail
1	Tests For Skin Sensitization	ISO 10993-10:2021	Skin Sensitization Test: Grades less than 1, otherwise sensitization.	Fern Green, Blue Sky, Midnight Black: No sensitization response was observed in control and treatment group animals. Classified as "non-sensitizer".	Pass
2	Tests For Skin Irritation	ISO 10993-23:2021	Skin Irritation Test: Primary irritation index 0-0.4 (Negligible), 0.5-1.9 (Slight), 2-4.9 (Moderate), 5-8 (Severe). (Implied goal is negligible or slight irritation).	Fern Green, Blue Sky, Midnight Black: No abnormality detected in animals. Classified as "non-irritant".	Pass
3	In Vitro Cytotoxicity	ISO 10993-5:2009	Cell viability reduced to <70% of the blank indicates cytotoxic potential.	Fern Green, Blue Sky, Midnight Black: Cell viability post treatment with 25%, 50%, and 100% test item extracts observed was less than 70% when compared to the vehicle control at all concentrations except 12.5%. Hence, the test item extract was considered to be cytotoxic. (However, the device passed Acute Systemic Toxicity).	Fail
4	Systemic Toxicity	ISO 10993-11:2017	No adverse systemic reactions.	Fern Green, Blue Sky, Midnight Black: No animal deaths or loss in body weight. Did not reveal systemic toxicity.	Pass
5	Residual Powder on Medical Gloves	ASTM D6124-06 (2022)	Powder residue limit of 2.0 mg/glove.	Fern Green: 0.6 mg/glove. Blue Sky: 0.9 mg/glove. Midnight Black: 0.8 mg/glove.	Pass
6	Detection of Holes in Medical Gloves	ASTM D5151-2006	Freedom from holes, AQL: 2.5 (ISO 2859).	Fern Green, Blue Sky, Midnight Black: 0 Glove leakage.	Pass
7	Physical dimensions (Length)	ASTM D6319-19	S: Length ≥ 220 mm; M: Length ≥ 230 mm; L: Length ≥ 230 mm; XL: Length ≥ 230 mm.	Fern Green: S: 241 mm, M: 253 mm, L: 255 mm, XL: 257 mm. Blue Sky: S: 242 mm, M: 251 mm, L: 254 mm, XL: 254 mm. Midnight Black: S: 240 mm, M: 253 mm, L: 254 mm, XL: 253 mm. (All pass)	Pass
	Physical dimensions (Width)	ASTM D6319-19	S: 80 ± 10 mm; M: 95 ± 10 mm; L: 110 ± 10 mm; XL: 120 ± 10 mm.	Fern Green: S: 85 mm, M: 97 mm, L: 110 mm, XL: 118 mm. Blue Sky: S: 82 mm, M: 97 mm, L: 111 mm, XL: 118 mm. Midnight Black: S: 84 mm, M: 98 mm, L: 109 mm, XL: 119 mm. (All pass)	Pass
	Thickness (Finger)	ASTM D3767-03	Finger ≥ 0.05 mm.	Fern Green: 0.11 mm. Blue Sky: 0.09 mm. Midnight Black: 0.10 mm. (All pass)	Pass
	Thickness (Palm)	ASTM D3767-03	Palm ≥ 0.05 mm.	Fern Green: 0.06 mm. Blue Sky: 0.08 mm. Midnight Black: 0.07 mm. (All pass)	Pass
8	Physical properties: Before aging (Tensile Strength)	ASTM D412-16	Tensile strength ≥ 14MPa.	Fern Green: 17.23 MPa. Blue Sky: 17.17 MPa. Midnight Black: 17.25 MPa. (All pass)	Pass
	Physical properties: Before aging (Ultimate Elongation)	ASTM D412-16	Ultimate Elongation ≥ 500%.	Fern Green: 540%. Blue Sky: 539%. Midnight Black: 541%. (All pass)	Pass
9	Physical properties: After Accelerated Aging (Tensile Strength)	ASTM D412-16	Tensile strength ≥ 14MPa.	Fern Green: 16.30 MPa. Blue Sky: 16.32 MPa. Midnight Black: 16.23 MPa. (All pass)	Pass
10	Physical properties: After Accelerated Aging (Ultimate Elongation)	ASTM D412-16	Ultimate Elongation ≥ 400%.	Fern Green: 450%. Blue Sky: 449%. Midnight Black: 452%. (All pass)	Pass

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document extensively lists the accepted criteria for various tests, but it does not explicitly state the sample sizes used for each specific test in the provided tables. For example, for "Detection of Holes", it simply states "0 Glove leakage" without indicating how many gloves were tested to achieve this. Similarly, for biocompatibility tests, it reports results (e.g., "No sensitization response") but not the number of animals or cells used.

The data provenance (country of origin, retrospective/prospective) is also not specified in the provided text. The submission is from 3A Glove Sdn. Bhd. (Malaysia), with a designated correspondent in Shanghai, China, but this doesn't clarify where the tests themselves were conducted or the origin of the samples.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable as the document describes non-clinical performance testing for medical devices (gloves), not a diagnostic device or AI system that requires expert interpretation for establishing ground truth. The tests are based on objective physical, chemical, and biological measures against established standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable for the same reason as point 3. Adjudication methods are typically used in clinical studies or studies involving human interpretation of data where consensus among experts is needed.

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

This information is not applicable as the document is for a medical device (patient examination gloves) and not an AI-assisted diagnostic device. No comparative effectiveness study with human readers or AI assistance was conducted or discussed.

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

This information is not applicable as the device is a patient examination glove, not an algorithm or software. Therefore, there is no "standalone" algorithm performance to report.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the non-clinical performance tests is based on established objective measurements and standardized test methods as defined by recognized international and national standards (ISO, ASTM). For example:

Biocompatibility: Adherence to biological response criteria in animal models (ISO 10993 series).
Physical Properties: Measurement of dimensions, tensile strength, and elongation against specifications in ASTM standards (e.g., D6319, D412).
Hole Detection: Compliance with acceptable quality levels (AQL) as per statistical sampling plans (ASTM D5151, ISO 2859).
Powder Content: Direct measurement against a defined limit (ASTM D6124).

The acceptance criteria themselves serve as the "ground truth" that the device must meet.

8. The sample size for the training set

This information is not applicable. The device is a physical product (nitrile gloves), not an artificial intelligence or machine learning system that requires a "training set."

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

This information is not applicable for the same reason as point 8. No training set or associated ground truth establishment is relevant to the conformity testing of patient examination gloves.

Summary

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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 and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters.

October 6, 2023

3A Glove Sdn. Bhd. % Boyle Wang General Manager Shanghai Truthful Information Technology Co., Ltd. Room 608, No. 738, Shangcheng Rd., Pudong Shanghai, Shanghai 200120 China

Re: K230777

Trade/Device Name: Patient Examination Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA Dated: September 6, 2023 Received: September 7, 2023

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.

Allan T

For Bifeng Qian, M.D., Ph.D. Assistant Director DHT4B: Division of Infection Control

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and Plastic and Reconstructive 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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Indications for Use

510(k) Number (if known) K230777

Device Name Patient Examination Gloves

Indications for Use (Describe)

The Patient Examination Gloves are disposable devices intended for medical purposes that are 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)

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

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510(k) Summary K230777

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

1.0 submitter's information

Name: 3A Glove Sdn. Bhd. Address: PTD 2058 & 2059, Jalan Cyber 4, Kawasan Perindustrian Senai (III), 81400 Senai, Johor, Malaysia Phone Number: +60127708756 Contact: Poh Seng Ping Date of Preparation: 2023.09.26

Designated Submission Correspondent

Mr. Boyle Wang Shanghai Truthful Information Technology Co., Ltd. Tel: +86-21-50313932 Email: Info@truthful.com.cn

2.0 Device information

Trade name: Patient Examination Gloves Common name: Patient Examination Gloves Classification name: Non-powdered patient examination glove Model(s): S. M. L. XL Colors: FERN GREEN/ MIDNIGHT BLACK/ SKY BLUE

3.0 Classification

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

4.0 Predicate device information

Manufacturer: Ever Global (Vietnam) Enterprise Corp Device: Disposable Powder Free Nitrile Examination Glove, White/ Blue/ Black/ Pink Color

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510(k) number: K171422

5.0 Indications for use

The Patient Examination Gloves are disposable devices intended for medical purposes that are worn on the examiner's hands to prevent contamination between patient and examiner.

6.0 Device description

7.0 Summary comparing technological characteristics with predicate device

Item	Proposed device	Predicate device	Remark
510(k) number	K230777	K171422	Same
Product Code	LZA	LZA	Same
Regulation No.	21CFR880.6250	21CFR880.6250	Same
Class	I	I	Same
Indications for use	The Patient ExaminationGloves is a disposabledevice intended formedical purposes that isworn on the examiner'shands to preventcontamination betweenpatient and examiner.	The Disposable PowderFree Nitrile ExaminationGlove, White/ Blue/ Black/Pink Color is a disposabledevice intended formedical purposes that isworn on the examiner'shands to preventcontamination betweenpatient and examiner.	Same
Powdered or Powder free	Powder free	Powder free	Same
Design Feature	ambidextrous	ambidextrous	Same
Labeling Information	Single-use indication,powder free, device color,device name, glove sizeand quantity, PatientExamination Gloves,Non-Sterile	Single-use indication,powder free, device color,device name, glove sizeand quantity, DisposablePowder Free NitrileExamination Glove,Non-Sterile	Same

Table1-General Comparison

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Predicate	Designation	Size				Tolerance
Device(K171422)	Length, mm	XS230	S230	M230	L230	XL230	min
	Width, mm	75	85	95	105	115	±5
	Thickness, mm:
	Finger	0.05					min
	Palm	0.05					min
Proposed Device	Designation	Size				Tolerance
	Length, mm	S220	M230	L230	XL230		min
	Width, mm	80	95	110	120		±10
	Thickness, mm:
	Finger	0.05					min
	Palm	0.05					min
Remark	Analysis1

Table2 Device Dimensions Comparison

Analysis1: The sizes and tolerances of proposed device are different with those of the predicate, but they all meet the requirements of ASTM D6319-19.

Item		Proposed device	Predicate device	Remark
Color		FERN GREEN/ MIDNIGHTBLACK/ SKY BLUE	White/ Blue/ Black/ Pink	Analysis 2
PhysicalProperties	BeforeAging	TensileStrength	14MPa, min	14MPa, min	SAME
		UltimateElongation	500%min	500%min	SAME
	AfterAging	TensileStrength	14MPa, min	14MPa, min	SAME
		UltimateElongation	400%min	400%min	SAME
	Comply with ASTM D6319			Comply with ASTM D6319	SAME
Freedom from Holes			Be free from holes whentested in accordance withASTMD5151 AQL=2.5	Be free from holes whentested in accordance withASTMD5151 AQL=2.5	SAME
Powder Content			Fern Green 0.6 mg/gloveMidnight black 1.1 mg/gloveSky blue 1.0 mg/glove	Meet the requirements ofASTM D6124	SIMILAR

Table3 Performance Comparison

Analysis 2: The proposed device has different color to the predicate device, but all proposed devices are conducted the performance tests.

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Item	Proposed device	Predicate device	Remark
Material	Nitrile	Nitrile	SAME
Biocompatibility	Irritation	Under the conditions of the study, not an irritant	Comply with ISO10993-10	SAME
	Sensitization	Under conditions of the study, not a sensitizer.
	Cytotoxicity	Under the conditions of the study, the device is potentially cytotoxic	Comply with ISO10993-5	Analysis 3
	Systemic toxicity	Under the conditions of the study, the device does not elicit an acute systemic toxicity response.	Complies with ISO 10993-11 Third edition 2017-09
Label and Labeling	Meet FDA's Requirement		Meet FDA's Requirement	SAME

Table4 Safety Comparison

Analysis 3: The proposed device is potentially cytotoxic, but all proposed devices passed the acute systemic toxicity test.

8.0 Summary of Non-Clinical Performance Testing

The following performance data has been provided to demonstrate that the subject device meets the acceptance criteria in the standard.

Table 5 Summary of Non-Clinical Performance Testing

No.	Name of theTestMethodology	Standard	AcceptanceCriteria	Results	Pass/ Fail
1	Tests For SkinSensitization	ISO10993-10:2021.	SkinSensitizationTest:providedgrades lessthan 1,otherwisesensitization.	Fern Green:No sensitization response was observed in control and treatment group animals.Based on results of the study, it is inferred that the polar and non-polar extracts of the test item “Powder Free Nitrile Examination Gloves Color: Fern Green” is classified as “non-sensitizer” and has met the skin sensitization test requirement of ISO 10993-10:2021.	Pass
				Blue Sky:No sensitization response was observed in control	Pass

				and treatment group animals.
				Based on results of the study, it is inferred that the
				polar and non-polar extracts of the test item
				"Powder Free Nitrile Examination GlovesColor: Blue Sky" is classified as "non-sensitizer" and
				has met the skin sensitization test requirement ofISO 10993-10:2021.
				Midnight Black:	Pass
				No sensitization response was observed in controland treatment group animals.
				Based on results of the study, it is inferred that thepolar and non-polar extracts of the test item
				"Powder Free Nitrile Examination GlovesColor: Midnight Black" is classified as"non-sensitizer" and has met the skin sensitizationtest requirement of ISO 10993-10:2021.

2	Tests For skinIrritation	ISO10993-23:2021.	Skin IrritationTest:If the primaryirritationindexis0-0,4, theresponsecategory isNegligible.0,5-1,9means slight2-4,9 meansmoderate5-8 meanssevere	Fern Green:At necropsy, there was no abnormality detected inany of the animals.the test item "POWDER FREE NITRILEEXAMINATION GLOVES COLOR: FERN GREEN"is "non-irritant" to the New Zealand white rabbitsand has met the skin irritation test requirement ofISO 10993-23:2021.	Pass

				Blue Sky:	Pass
				At necropsy, there was no abnormality detected inany of the animals.Based on results of the study, it is inferred that thepolar and non-polar extracts of the test item"POWDER FREE NITRILE EXAMINATIONGLOVES COLOR: Blue Sky" is "non-irritant" to theNew Zealand white rabbits and has met the skinirritation test requirement of ISO 10993-23:2021.

				Midnight Black:At necropsy, there was no abnormality detected inany of the animals.Based on results of the study, it is inferred that thepolar and non-polar extracts of the test item"POWDER FREE NITRILE EXAMINATIONGLOVES COLOR: Midnight Black" is "non-irritant"	Pass
to the New Zealand white rabbits and has met theskin irritation test requirement of ISO10993-23:2021.
3	In VitroCytotoxicity	ISO10993-5:2009	The viab.%of the 100%extract of thetest article isthe finalresult, and ifviability isreduced to<70% of theblank, it hascytotoxicpotential.	Fern Green:Cell viability post treatment with 25, 50 and 100 %test item extracts in MTT test observed was lessthan 70% when compared to the vehicle control atall the concentrations except at the 12.5% test itemconcentration. Hence, test item extract wasconsidered to be cytotoxic.Blue Sky:Cell viability post treatment with 25, 50 and 100 %test item extracts in MTT test observed was lessthan 70% when compared to the vehicle control atall the concentrations except at the 12.5% test itemconcentration. Hence, test item extract wasconsidered to be cytotoxic.Midnight Black:Cell viability post treatment with 25, 50 and 100 %test item extracts in MTT test observed was lessthan 70% when compared to the vehicle control atall the concentrations except at the 12.5% test itemconcentration. Hence, test item extract wasconsidered to be cytotoxic.	Fail
4	Systemictoxicity	ISO10993-11:2017	To evaluatethe potentialfor medicaldevicematerials tocauseadversesystemicreactions.	Fern Green:No animal deaths or loss in body weight.Based on results of the study, it is inferred that thetest item "POWDER FREE NITRILE EXAMINATIONGLOVES COLOR: FERN GREEN" did not revealsystemic toxicity and has met the acute systemictoxicity test requirement of ISO 10993-11:2017.Blue Sky:No animal deaths or loss in body weight.Based on results of the study, it is inferred that thetest item "POWDER FREE NITRILE EXAMINATIONGLOVES COLOR: BLUE SKY" did not revealsystemic toxicity and has met the acute systemictoxicity test requirement of ISO 10993-11:2017.	Pass

				Midnight Black:No animal deaths or loss in body weight.Based on results of the study, it is inferred that thetest item "POWDER FREE NITRILE EXAMINATIONGLOVES COLOR: MIDNIGHT BLACK" did notreveal systemic toxicity and has met the acutesystemic toxicity test requirement of ISO10993-11:2017.	Pass
5	ResidualPowder onMedicalGloves	ASTMD6124-06(2022)	powderresidue limitof 2.0mg/glove	Fern Green:Average: 0.6 mg/gloveBlue Sky:Average: 0.9 mg/gloveMidnight Black:Average: 0.8 mg/glove	Pass
6	Detection ofHoles inMedicalGloves	ASTMD5151-2006	Freedomfree holeAQL: 2.5(ISO 2859)	Fern Green:0 Glove leakageBlue Sky:0 Glove leakageMidnight Black:0 Glove leakage	Pass
7	Physicaldimensions	ASTMD6319-19	S: width $80 \pm$10mmLength $\geq$220 mm	Fern Green:Average Length: 241 mmAverage width: 85 mmBlue Sky:Average Length: 242 mmAverage width: 82 mmMidnight Black:Average Length: 240 mmAverage width: 84 mm	Pass
			M: width $95 \pm$10mmLength $\geq$230 mm	Fern Green:Average Length: 253 mmAverage width: 97 mmBlue Sky:Average Length: 251 mmAverage width: 97 mm	Pass

			Midnight Black:Average Length: 253 mmAverage width: 98 mm	Pass


		L: width 110±10mmLength ≥230 mm	Fern Green:Average Length: 255mmAverage width: 110 mm	Pass


			Blue Sky:Average Length: 254 mmAverage width: 111 mm	Pass


		XL: width120±10mmLength ≥230 mm	Midnight Black:Average Length: 254 mmAverage width: 109 mm	Pass


		Fern Green:Average Length: 257 mmAverage width: 118 mm	Pass


			Blue Sky:Average Length: 254 mmAverage width: 118 mm	Pass


Thickness	ASTMD3767-03(2003)	Finger ≥0.05 mm	Midnight Black:Average Length: 253 mmAverage width: 119 mm	Pass


Fern Green:Average thickness: 0.11 mm	Pass

Blue Sky:Average Length: 0.09 mm	Pass

Midnight Black:Average Length: 0.10 mm	Pass

Palm ≥0.05mm	Fern Green:Average Length: 0.06 mm	Pass

Blue Sky:Average Length: 0.08 mm	Pass

Midnight Black:Average Length: 0.07 mm	Pass
Physicalproperties:Before aging	ASTMD412-16


		>14MPa	Fern Green:	Pass

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strength		Average Tensile strength: 17.23 MPa
		Blue Sky:
		Average Tensile strength: 17.17 MPa
		Midnight Black:
		Average Tensile strength: 17.25 MPa
UltimateElongation	≥500%	Fern Green:Average Ultimate Elongation: 540%	Pass
		Blue Sky:Average Ultimate Elongation: 539%
		Midnight Black:Average Ultimate Elongation: 541%
AfterAcceleratedAgingTensilestrength	≥14MPa	Fern Green:Average Tensile strength: 16.30 MPa	Pass
		Blue Sky:Average Tensile strength: 16.32 MPa
		Midnight Black:Average Tensile strength: 16.23 MPa
UltimateElongation	≥400%	Fern Green:Average Ultimate Elongation: 450%	Pass
		Blue Sky:Average Ultimate Elongation: 449%
		Midnight Black:Average Ultimate Elongation: 452%

9. Summary of Clinical Performance Test

No clinical study is included in this submission.

10.0 Conclusion

The conclusions drawn from the nonclinical tests demonstrate that the proposed device is as safe, as effective, and performs as well as or better than the legally marketed predicate device, K171422.

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.