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 Disposable Nitrile Examination Gloves are ambidextrous, non-sterile, powder-free, and is made of nitrile (Acrylonitrile-butadiene copolymer) and chemical additives. It has a finger textured surface and is colored blue. This is a single use, disposable device(s), provided non-sterile.

AI/ML Overview

The provided text describes the acceptance criteria and performance of "Disposable Nitrile Examination Gloves" (K210897) in comparison to a predicate device (K192333), as part of an FDA 510(k) summary.

Here's a breakdown of the requested information:

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

| Characteristics | Acceptance Criteria | Proposed Device Performance (Disposable Nitrile Examination Gloves - K210897) | Predicate Device Performance (Blue Nitrile Examination Gloves Powder Free - K192333) |
|---------------------------|--------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| Comparison |
| General Comparison | | | | |
| 510K Number | / | K210897 | K192333 | - |
| Product Code | LZA | LZA | LZA | Same |
| Classification | Class I (21 CFR 880.6250) | Class I (21 CFR 880.6250) | Class I (21 CFR 880.6250) | Same |
| Intended Use | A 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. The device is for over-the-counter use. | 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. | A powder free patient examination gloves 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. | Same |
| Material Use | Nitrile | Nitrile | Nitrile | Same |
| Color | Blue | Blue | Blue | Same |
| Sterility | Non-sterile | Non-sterile | Non-sterile | Same |
| Performance Testing | | | | |
| Dimensions (ASTM D6319-19) | Overall Length (mm): 220 mm = (sizes XS-S), 230 mm = (sizes M-XL); Width (± 10 mm): Size S = 80 mm, Size M = 95 mm, Size L = 110 mm, Size XL = 120 mm; Thickness at Finger (mm): All Sizes = 0.05mm; Thickness at Palm (mm): All Sizes = 0.05mm | Length (mm): 220 mm = (sizes XS-S), 230 mm = (sizes M-XL); Width (± 10 mm): Size S = 80 mm, Size M = 95 mm, Size L = 110 mm, Size XL = 120 mm; Thickness-Finger (mm): All Sizes ≥ 0.05mm; Thickness-Palm (mm): All Sizes ≥ 0.05mm | Size: M, Length Min: 230mm, Palm Width Min: 95+/-10mm, Finger Thickness min: 0.05 mm, Palm Thickness min: 0.05 mm | Same |
| Tensile Strength (Before Aging ASTM D6319-19) | $\ge$ 14 MPa | > 14 min MPa | > 14 min MPa | Same |
| Ultimate Elongation (Before Aging) | $\ge$ 500% | 500 min % | 500 min % | Same |
| Tensile Strength (After Aging ASTM D6319-19) | $\ge$ 14 MPa | $\ge$ 14 min MPa | $\ge$ 14 min MPa | Same |
| Ultimate Elongation (After Aging) | $\ge$ 400% | 400 min % | 400 min % | Same |
| Freedom from Holes (ASTM D5151) | AQL 2.5 Inspection Level G-1 | Passes AQL-2.5 | Passes AQL-2.5 | Same |
| Residual Powder (ASTM D6124) | $\le$ 2.0 mg/pc | $\le$ 2.0 mg/pc | $\le$ 2.0 mg/pc | Same |
| Biocompatibility Testing | | | | |
| Primary Skin Irritation Test (ISO 10993-10) | Not an irritant | Under the conditions of the test, the test article would be considered a non-irritant. | Under the condition of study not an irritant. | Same |
| Dermal Sensitization Assay (ISO 10993-10) | Not a sensitizer | Under the conditions of this study, there is no evidence of skin sensitization in guinea pigs was found. | Under the conditions of the study not a sensitizer. | Same |
| Acute Systemic Test (ISO 10993-11) | No mortality or evidence of systemic toxicity | Under the conditions of this study, there is no mortality or evidence of systemic toxicity from the extracts. The test met the test requirements. | Under the condition of study the device extracts do not pose a systemic toxicity concern. | Same |
| Material Mediated Pyrogenicity (ISO 10993-11/USP 41<151>) | No febrile reaction; meets requirements | Under the conditions of this study, the test article would be considered no febrile reaction. The test article meets the test requirements. | Under the conditions of the study, the device did not demonstrate a material mediated pyrogenicity response. | Same |
| In Vitro Cytotoxicity (ISO 10993-5) | Not cytotoxic (or acceptable cytotoxicity with further testing/justification) | Under the conditions of this study, the MEM test extracts would be considered cytotoxic potential. | Under the conditions of the study, cytotoxic. Additional testing was performed to determine if this was a systemic toxicity concern. | Same |
| Intracutaneous Reactivity Test (ISO 10993-10) | Polar and non-polar extract score less 1.0; requirements met | The test result showed that the polar and non-polar extract of the final test sample score is less 1.0, the requirements of the test are met. | Not available. | N/A |

A key point is that for all tested Biocompatibility characteristics, the proposed device's performance aligns with the predicate device, with one notable difference for "In Vitro Cytotoxicity" where both devices were found to be cytotoxic, but the predicate device had "Additional testing was performed to determine if this was a systemic toxicity concern," implying the cytotoxicity might have been addressed or deemed acceptable in the predicate's clearance. The proposed device's statement "would be considered cytotoxic potential" suggests a similar outcome, and the "Same" comparison indicates this was consistent with the predicate.

The study that proves the device meets the acceptance criteria:

The study proving the device meets the acceptance criteria is a non-clinical test program that evaluates the "Disposable Nitrile Examination Gloves" against recognized industry standards and FDA guidance. This is explicitly stated in section 8: "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."

The comparison tables (Table II - Performance Testing Comparison Table and Table III - Biocompatibility Testing Comparison Table) demonstrate that the proposed device's performance meets or exceeds the specified acceptance criteria and is substantially equivalent to the predicate device.

Absence of information for AI-specific questions:

The provided document is an FDA 510(k) summary for a medical device (disposable nitrile examination gloves). It does not pertain to an AI/ML-enabled medical device. Therefore, the following information is not applicable and not present in the document:

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
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)
Adjudication method (e.g. 2+1, 3+1, none) for the test set
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
If a standalone (i.e. algorithm only without human-in-the loop performance) was done
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The sample size for the training set
How the ground truth for the training set was established

The testing performed for this device relates to physical properties (dimensions, tensile strength, elongation, freedom from holes, residual powder) and biocompatibility (skin irritation, sensitization, systemic toxicity, pyrogenicity, cytotoxicity, intracutaneous reactivity), which are standard evaluations for such a product.

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). 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.

August 24, 2021

Shandong DS Safety Technology Co., Ltd. % Rafi Wong Manager Pacific Fortune Management Inc. 2350 Mission College Blvd. Ste 475 Santa Clara, California 95054

Re: K210897

Trade/Device Name: Disposable 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: July 19, 2021 Received: July 26, 2021

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.

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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 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, 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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Indications for Use

510(k) Number (if known)

K210897

Device Name

Disposable Nitrile Examination Gloves

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
Research involving rCBH subjects only
Secondary Research involving rCBH subjects only

| | Prescription Use (Part 21 CFR 801 Subpart D)

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

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510K SUMMARY

Date of Summary Prepared: August 24,2021

510K Number: K210897

1. Submitter Information

Submitter Contact:

Address:	SHANDONG DS SAFETY TECHNOLOGY CO.,LTD.
	West of Yaoqian Road, Yaogezhuang Community,
	Economic Development Zone, Gaomi City, Weifang City
	Shandong 261502, China

Submitter Contact Person:

Name:	Summer Feng
Phone Number:	+86-0536-2586046
Email:	summer@dsgloves.com

Designated Submission Correspondent:

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

1. Device Name: Disposable Nitrile Examination Gloves

3. Regulatory Information

Common Name:	Polymer Patient Examination Glove
Apparel Classification:	Class I
Product Code:	LZA

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Regulation Number: 21 CFR 880.6250

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

6. Device Description

7. Summary of Comparison and Technological Characteristics

Characteristics	AcceptanceCriteria	ProposedDeviceDisposableNitrileExaminationGloves	Predicate DeviceBlue NitrileExaminationGloves PowderFree	Comparison
510K Number	/	K210897	K192333	-
Product Code	LZA	LZA	LZA	Same
Manufacturer	/	SHANDONGDS SAFETYTECHNOLOGYCO.,LTD.	JR Engineering &MedicalTechnologies (M)SDN.BHD.	Different

Table I - General Comparison

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Classification	Class I (21 CFR880.6250)	Class I (21 CFR880.6250)	Class I (21 CFR880.6250)	Same
Intended Use	A patientexamination gloveis a disposabledevice intended formedical purposesthat is worn on theexaminer's hands orfingers to preventcontaminationbetween patient andexaminer. Thedevice is for over-the-counter use.	A powder freepatientexaminationglove is adisposabledevice intendedfor medicalpurposes that isworn on theexaminer's handor finger topreventcontaminationbetween patientand examiner.The device is forover-the-counteruse.	A powder freepatientexaminationgloves is adisposable deviceintended formedical purposesthat is worn on theexaminer's hand orfinger to preventcontaminationbetween patientand examiner.	Same
Material Use	Nitrile	Nitrile	Nitrile	Same
Color	Blue	Blue	Blue	Same
Sterility	Non-sterile	Non-sterile	Non-sterile	Same

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

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. ISO 10993-5: 2009 Biological Evaluation Of Medical Devices – Part 5: Tests For In Vitro Cytotoxicity
AAMI / ANSI / ISO 10993-11: 2017 Biological Evaluation Of Medical Devices - Part 11: Tests For Systemic Toxicity
. 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

		ProposedDevice	Predicate Device
Characteristics	AcceptanceCriteria	Disposable NitrileExaminationGloves(K210897)	Blue NitrileExaminationGloves PowderFree (K192333)	Comparison
Dimensions(ASTM D6319-19)	Overall Length(mm)220 mm = (sizesXS-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 = 0.05mmThickness at Palm(mm)All Sizes = 0.05mm	Length (mm)220 mm = (sizesXS-S)230 mm = (sizesM-XL)Width (± 10 mm)Size S = 80 mmSize M = 95 mmSize L = 110 mmSize XL = 120mmThickness-Finger(mm)All Sizes≥0.05mmThickness-Palm(mm)All Sizes≥0.05mm	Size: MLength Min:230mmPalm Width Min:95+/-10mmFinger Thicknessmin: 0.05 mmPalm Thicknessmin: 0.05 mm	Same
PhysicalProperties	Tensile Strength(MPa) = 14 min.	Before Aging ASTM D6319-19Tensile Strength(MPa)> 14 min	Tensile Strength(MPa)> 14 min.	Same

Table II - Performance Testing Comparison Table of proposed device K210897 and predicate device K192333

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	Ultimate Elongation(%) = 500 min.	UltimateElongation (%)500 min.	UltimateElongation (%)500 min.	Same
	After Aging ASTM D6319-19
	Tensile Strength(MPa) = 14 min.	Tensile Strength(MPa)$\ge$ 14 min.	Tensile Strength(MPa)$\ge$ 14 min.	Same
	Ultimate Elongation(%) = 400 min.	UltimateElongation (%)400 min.	UltimateElongation (%)400 min.	Same
Freedom fromHoles(ASTM D5151)	AQL 2.5 InspectionLevel G-1	Passes AQL-2.5	Passes AQL-2.5	Same
Residual Power(ASTM D6124)	$\le$ 2.0 mg/pc	$\le$ 2.0 mg/pc	$\le$ 2.0 mg/pc	Same

Table III - Biocompatibility Testing Comparison Table

Characteristics	AcceptanceCriteria	Proposed Device	PredicateDevice
		Disposable NitrileExaminationGloves	Blue NitrileExaminationGloves PowderFree	Comparison
Biocompatibility	Primary SkinIrritation TestISO 10993-10	Under theconditions of thetest, the test articlewould beconsidered a non-irritant.	Under thecondition ofstudy not anirritant.	Same
	DermalSensitizationAssayISO 10993-10	Under theconditions of thisstudy, there is noevidence of skinsensitization inguinea pigs wasfound.	Under theconditions of thestudy not asensitizer.	Same
	Acute SystemicTestISO 10993-11	Under theconditions of thisstudy, there is nomortality orevidence ofsystemic toxicityfrom the extracts.	Under thecondition ofstudy the deviceextracts do notpose a systemictoxicity concern.	Same

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	The test met the testrequirements.
MaterialMediatedPyrogenicityISO 10993-11/USP 41<151>	Under theconditions of thisstudy, the testarticle would beconsidered nofebrile reaction. Thetest article meetsthe testrequirements.	Under theconditions of thestudy, the devicedid notdemonstrate amaterialmediatedpyrogenicityresponse.	Same
In VitroCytotoxicityISO 10993-5	Under theconditions of thisstudy, the MEM testextracts would beconsideredcytotoxic potential.	Under theconditions of thestudy, cytotoxic.Additionaltesting wasperformed todetermine if thiswas a systemictoxicity concern.	Same
IntracutaneousReactivity TestISO 10993-10	The test resultshowed that thepolar and non-polarextract of the finaltest sample score isless 1.0, therequirements of thetest are met	Not available.	N/A

9. Clinical Test

There is no clinical study included in this submission.

10. Conclusion

The conclusion drawn from the nonclinical tests demonstrates that the subject device in 510(k) submission K210897, the Disposable Nitrile Examination Gloves , is as safe, as effective, and performs as well as or better than the legally marketed predicate device cleared under K192333.

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.