A powder free patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hands or fingers to prevent contamination between patient and examiner.

Device Description

The proposed device is a powder free medical glove. The device is made from a nitrile latex compound, blue in color. The device meets the requirements of ASTM D6319-19: Standard specification for Nitrile Examination Gloves for Medical Application. The device is available in five sizes, which are XS, S, M, L, XL, it could be selected by the user depended on size of hand. The different between each size is just in the dimension. The device can be provided in non-sterile.

AI/ML Overview

This document is a 510(k) Premarket Notification for "Medical Gloves" (K203622). It describes the device's characteristics, its intended use, and comparative testing against a predicate device (K180467) to demonstrate substantial equivalence.

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:

Device Under Evaluation: Medical Gloves (powder-free patient examination glove, nitrile latex compound, blue color)

1. Table of Acceptance Criteria and Reported Device Performance

Test Method	Purpose	Acceptance Criteria	Reported Device Performance
Freedom from Holes - ASTM D5151	Detection of holes that allow water leakage	Do not show droplet, stream or other type of water leakage (Meets ASTM D5151-19, AQL 2.5 Inspection, Level G-1, Accept at 5 failures, Reject at 6 failures).	No leakage (Meets ASTM D5151-19, AQL 2.5 Inspection, Level G-1, Accept at 5 failures, Reject at 6 failures).
Physical dimension - ASTM D6319	Evaluate the glove physical dimension	Length: >220 mm (XS and S sizes), >230 mm (M, L and XL sizes) Width (±10mm): XS = 70mm, S = 80mm, M = 95mm, L = 110mm, XL = 120mm Thickness at Finger (mm): All Sizes ≥ 0.05 mm Thickness at Palm: All Sizes ≥ 0.05 mm	Length: Larger than 220mm for XS and S size, Larger than 230mm for M, L and XL sizes Width: XS: within 70±10mm, S: within 80±10mm, M: within 95±10mm, L: within 110±10mm, XL: within 120±10mm Thickness: Larger than 0.05mm (at finger and palm)
Physical requirement - ASTM D412	Evaluate the physical requirement (Tensile Strength & Ultimate Elongation)	Before Aging (Min): Tensile strength: 14Mpa, Ultimate elongation: 500% After Aging (Min): Tensile strength: 14Mpa, Ultimate elongation: 400%	Before aging: Larger than 14Mpa and 500% After aging: Larger than 14Mpa and 400%
Powder residue - ASTM D6124	Evaluate the residue powder	Less than 2.0mg per glove.	Less than 2.0mg per glove.
Skin sensitization - ISO 10993-10	Evaluated for the potential to cause delayed dermal contact sensitization	Magnusson and Kligman grade shall be less than control group.	No skin sensitization.
Skin irritation - ISO 10993-10	Evaluated for the potential to cause skin irritation	No significant reaction than the control group.	No skin irritation.
Acute toxicity - ISO 10993-11	Evaluated for acute systemic toxicity	No significant reaction than the control group. Animal death or abnormal behavior no more than two animals. Body weight loss greater than 10% no more than 3 animals. (Note: Predicate device did not explicitly provide this data, but the proposed device showed no adverse effect.)	No acute toxicity. (Implies meeting all specified criteria).

Study that Proves the Device Meets the Acceptance Criteria (Non-Clinical Testing):

The document explicitly states: "Non clinical tests were conducted to provide data that the proposed devices met the acceptance criteria or the specification for the test methodology or standard shown below. The test results demonstrated that the proposed devices comply with the following standards."

2. Sample Size Used for the Test Set and the Data Provenance

Sample Size: The document does not explicitly state the specific number of gloves or animals used for each test. However, it references specific ASTM and ISO standards (e.g., ASTM D5151-19, which specifies AQL levels and inspection levels for Freedom from Holes). These standards define appropriate sample sizes for testing compliance. For instance, ASTM D5151-19, AQL 2.5, Inspection Level G-1 means the sample size is determined by the lot size, but for the specifically mentioned acceptance/rejection criteria (Accept at 5 failures, Reject at 6 failures), it implies a certain sample size bracket within the standard.
Data Provenance: The document does not specify the country of origin where the non-clinical tests were performed. It states the sponsor is Beijing Biosis Healing Biological Technology Co., Ltd. from China, so it's reasonable to infer the tests were conducted in or overseen by this entity. The data is retrospective in the sense that the tests were performed, and the results are being reported as part of a premarket submission.

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

This section talks about the establishment of ground truth for a test set, typically relevant for AI/ML device evaluations. This document describes the evaluation of a physical medical device (gloves) against established performance standards. Therefore, the "ground truth" is based on objective, standardized test methods and their defined acceptance criteria. It is not based on expert consensus interpreting subjective data.
The tests themselves are performed by trained personnel in a laboratory setting, but the document does not specify the number or qualifications of these individuals, as it's not a multi-reader study.

4. Adjudication Method for the Test Set

Not applicable. This is not a study involving human readers or subjective interpretations requiring adjudication. The tests are objective and based on physical measurements and chemical analyses as per established 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

Not applicable. This is not an AI/ML device that assists human readers. It is a physical medical device (gloves).

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

Not applicable. This is not an algorithm or AI device. The "standalone" performance refers to the device's ability to meet the specified performance criteria as tested in isolation according to the listed ASTM and ISO standards. The results table clearly indicates that the device met these criteria.

7. The Type of Ground Truth Used

The ground truth used for this device's evaluation is primarily objective, standardized test results based on established international (ISO) and national (ASTM) consensus standards. These standards define measurable physical, chemical, and biological properties, along with clear acceptance/rejection criteria. For biocompatibility tests (skin sensitization, irritation, acute toxicity), the ground truth is established by the biological responses observed in the test models (e.g., animal models) according to the protocols defined in ISO 10993.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device that requires a "training set." The device itself is a manufactured product, not a learned algorithm.

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

Not applicable, as there is no training set for this type of device.

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.

August 20, 2021

Beijing Biosis Healing Biological Technology Co., Ltd. % Diana Hong General Manager Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai. 200120 China

Re: K203622

Trade/Device Name: Medical Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA Dated: July 10, 2021 Received: July 19, 2021

Dear Diana Hong:

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

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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 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, 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

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K203622

Device Name Medical Gloves

Indications for Use (Describe)

A powder free patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hands or fingers to prevent contamination between patient and examiner.

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)

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510(k) Summary

This 510(k) Summary is being submitted in accordance with requirements of Title 21, CFR Section 807.92.

The assigned 510(k) Number: K203622

1. Date of Preparation: 08/19/2021
1. Sponsor Identification

Beijing Biosis Healing Biological Technology Co., Ltd. No.6 Plant West, Valley No.1 bio-medicine Industry Park, Daxing District, Beijing, 102600, China.

Establishment Registration Number: 3016668451

Contact Person: Ting Jiang Position: RA Director Tel: +86-10-61252660 Fax: +86-10-61252030 Email: Jiangting@biosishealing.com

1. Designated Submission Correspondent
  Ms. Diana Hong (Primary Contact Person) Ms. Ying Xu (Alternative Contact Person)

Mid-Link Consulting Co., Ltd. P.O. Box 120-119, Shanghai, 200120, China

Tel: +86-21-22815850, Fax: 360-925-3199 Email: info@mid-link.net

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K203622

Identification of Proposed Device 4.
Trade Name: Medical Gloves Common Name: Patient Examination Glove

Regulatory Information Classification Name: Non-powderedpatient examination glove Classification: I; Product Code: LZA Regulation Number: 21 CFR 880.6250 Review Panel: General Hospital

Indication for use:

A powder free patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hands or fingers to prevent contamination between patient and examiner.

Device Description:

ર. Identification of Predicate Device
510(k) Number: K180467 Product Name: SBG Blue Nitrile Powder Free Medical Examination Glove

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1. Technological Comparison:

ITEM	Proposed Device	Predicate Device	Remark
Product Code	K203622	K180467	Same
RegulationNumber	21 CFR 880.6250	21 CFR 880.6250	Same
Class	Class I	Class I	Same
Indication for use	A powder free patient examinationglove is a disposable deviceintended for medical purposes thatis worn on the examiner's hands orfingers to prevent contaminationbetween patient and examiner.	A powder free patientexamination glove is a disposabledevice intended for medicalpurposes that is worn on theexaminer's hands or fingers toprevent contamination betweenpatient and examiner.	Same
Material	Nitrile latex compound	Nitrile latex compound	Same
Color	Blue	Blue	Same
Sterility	Non-sterile	Non-sterile	Same
Model	XS, S, M, L, XL	S, M, L, XL	Analysis 1
Dimensions(ASTM D6319-19)	> 220 mm (XS and S sizes)> 230 mm (M, L and XL sizes)Width(±10mm)XS = 70mmS = 80mmM = 95mmL = 110mmXL = 120mmThickness at Finger (mm)All Sizes ≥ 0.05 mmThickness at PalmAll Sizes ≥ 0.05 mm	Overall Length (mm)220 mm = (sizes XS-S)230 mm = (sizes M-XL)Width (± 10 mm)Size S = 80 mmSize M = 95 mmSize L = 110 mmSize XL = 120 mmThickness at Finger (mm)All Sizes = 0.05 mmThickness at PalmAll Sizes = 0.05 mm	Analysis 2
Physical Properties(ASTM D6319-19andASTMD412-16)	Before AgingTensile Strength ≥ 14MpaUltimate Elongation ≥ 500%After AgingTensile Strength ≥ 14MpaUltimate Elongation ≥ 400%	Before AgingTensile Strength ≥ 14MpaUltimate Elongation ≥ 500%After AgingTensile Strength ≥ 14MpaUltimate Elongation ≥ 400%	Analysis 3
Powder free residue(ASTM D6319-19 and ASTM D6124-06)	Less than 2 mg per glove	Less than 2 mg per glove	Analysis 4
Freedom from Holes(ASTM D5151-19)	AQL 2.5 InspectionLevel G-1Accept at 5 failuresReject at 6 failuresMeets ASTM D5151-19	AQL 2.5 InspectionLevel G-1Accept at 5 failuresReject at 6 failuresMeets ASTM D5151-06	Analysis 5
Skin Irritation	No Irritation	No Irritation	Same
Sensitization	No Sensitization	No Sensitization	Same
Acute toxicity	No acute toxicity	/	Analysis 6

Table 1 General
Technological Comparison

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Analysis 1 - Model

The proposed device has the additional XS size compared to predicate device. A various sizes could provide more choices for users and the different size does not affect intended use. In addition, the size XS of proposed device has been tested and the test result demonstrated that it could meet the requirements of ASTM D6319-19. Therefore, it can be considered that this difference does not affect substantially equivalence on safety and effectiveness.

Analysis 2 - Dimensions

The dimensions of proposed device are different from predicate device 1. The proposed device has one more XS size and the minimum length of proposed device is larger than the predicate device 1. In addition, the proposed device was tested according to the ASTM D6319-19 while the predicate device 1 was tested according to ASTM D6319-10. However, these two standards are just different in version and all test results of dimensions for proposed device could met the requirements of ASTM D6319 -19. Therefore, it can be considered that this difference does not affect substantially equivalence on safety and effectiveness.

Analysis 3 - Physical Properties

The standard version of Physical Properties requirements for the proposed device is different from the predicated device 1. The proposed device was tested and met the requirements of ASTM D6319 -19 while the predicate device 1 was tested and met the requirements of ASTM D6319-10. However, these two standards are just different in version. Therefore, it can be considered that this difference does not affect substantially equivalence on safety and effectiveness.

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Analysis 4 - Powder free residue

The standard version of Powder free residue requirements for the proposed device is different from the predicated device 1. The proposed device was tested and met the requirements of ASTM D6319 -19 while the predicate device 1 was tested and met the requirements of ASTM D6319-10. However, these two standards are just different in version. Therefore, it can be considered that this difference does not affect substantially equivalence on safety and effectiveness.

Analysis 5 - Freedom from Holes

The standard version of Freedom from Holes requirements for the proposed device is different from the predicated device 1. The proposed device was tested and met the requirements of ASTM D5151 -19 while the predicate device 1 was tested and met the requirements of ASTM D5151-06. However, these two standards are just different in version. Therefore, it can be considered that this difference does not affect substantially equivalence on safety and effectiveness.

Analysis 6-Biocompabitlity

The contact level and duration for the proposed device is intact skin and limited contact. Cytotoxicity, Skin sensitization and irritation shall be evaluated for the proposed device per FDA guidance. Acute toxicity test was evaluated for the proposed device instead of cytotoxicity. The test result showed that there was no adverse effect. Therefore, it can be considered that the proposed device is safety as the predicate device.

7. Non-Clinical Testing:

Non clinical tests were conducted to provide data that the proposed devices met the acceptance criteria or the specification for the test methodology or standard shown below. The test results demonstrated that the proposed devices comply with the following standards:

A 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 D3767-03 Standard Practice for Rubber-Measurement of Dimensions
ASTM D412-16 Standard Test Methods for Vulcanized Rubber and Thermoplastic Elastomers-Tension
A ASTM D6124-06 (Reapproved 2017) Standard Test Method for Residual Powder on Medical Gloves
A ISO 10993-10:2010 Biological Evaluation of Medical Devices-Part 10: Tests for Irritation and Skin Sensitization;

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Test Method	Purpose	Acceptance Criteria	Results
Freedom from Holes-ASTMD5151	Detection the holes thatallow water leakage	Do not show droplet, streamor other type of waterleakage	No leakage
Physical dimension-ASTMD6319	Evaluate the glovephysical dimension	Length: >220 mm (XS andS sizes)Length: >230 mm(M, L and XL sizes)Width (±10mm)XS = 70mmS = 80mmM = 95mmL = 110mmXL = 120mmThickness at Finger (mm)All Sizes ≥ 0.05 mmThickness at PalmAll Sizes ≥ 0.05 mm	LengthLarger than 220mm forXS and S sizeLarger than 230mm forM, L and XL sizesWidthXS: within 70±10mmS: within 80±10mmM: within 95±10mmL: within 110±10mmXL: within 120±10mmThicknessLarger than 0.05mm
Physical requirement-ASTMD412	Evaluate the physicalrequirement	Before Aging (Min)Tensile strength: 14MpaUltimate elongation: 500%After Aging (Min)Tensile strength: 14MpaUltimate elongation: 400%	Before agingLarger than 14Mpa and500%After agingLarger than 14Mpa and400%
Powder residue-ASTM D6214	Evaluate the residuepowder	Less than 2.0mg	Less than 2.0mg
Skin sensitization-ISO 10993-10	Evaluated for the potentialto cause delayed dermalcontact sensitization	Magnusson and Kligmangrade shall be less thancontrol group	No skin sensitization
Skin irritation-ISO 10993-10	Evaluated for the potentialto cause skin irritation	No significant reaction thanthe control group	No skin irritation
Acute toxicity-ISO 10993-11	Evaluated for acutesystemic toxicity	No significant reaction thanthe control groupAnimal death or abnormalbehaviour no more than twoanimalsBody weight loss greaterthan 10% no more than 3animals	No acute toxicity

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8. Conclusion

The conclusion drawn from the nonclinical tests demonstrates that the subject device in 510(k) submission K203622, the Medical Gloves, is as safe, as effective, and performs as well as or better than the legally marketed predicate device cleared under K180467.

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.