Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) 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.

Device Description

Poly Vinyl Chloride (PVC) films form a barrier to prevent contamination between patient and examiner. The PVC rubber is water tight under normal conditions of use. It's tensile properties cause it to conform to the hand, allowing movements necessary for a medical procedure. The Poly (vinyl chloride) glove acts as a barrier to prevent contamination between patient and examiner. The glove is manufactured in accordance with the requirements of ASTM D5250 and ASTM D5151.

AI/ML Overview

This document is a 510(k) Pre-Market Notification for Powder Free Vinyl Patient Examination Gloves. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving a novel device meets specific acceptance criteria in a clinical setting.

Therefore, many of the requested sections are not applicable in this context. However, I can extract information related to the device's technical specifications and the non-clinical tests performed to ensure it meets established safety and performance standards for gloves.

Here's a breakdown of the relevant information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally defined by compliance with established ASTM and ISO standards for medical examination gloves. The reported device performance is presented as meeting these standards.

Characteristic	Acceptance Criteria (Standard)	Reported Device Performance
Dimension		Width (mm)
Width (Small)	80-90 mm	82-88
Width (Medium)	90-100 mm	94-98
Width (Large)	100-110 mm	103-109
Width (X-Large)	110-120 mm	114-117
		Thickness (mm)
Fingertip	≥0.05 mm (ASTM D 5250-06)	0.09-0.10
Palm	≥0.08 mm (ASTM D 5250-06)	0.10-0.11
Physical Properties	ASTM D 5250-06 (Reapproved 2015)
Tensile Strength (Before & After aging)	≥11 MPa	15-22 MPa
Elongation Rate (Before & After aging)	≥300%	350-420%
Freedom from Pinholes	Holes at Inspection Level I AQL2.5 (21 CFR 800.20, ASTM D5250-06, ASTM D5151-19)	Met Acceptance Criteria; Holes at Inspection Level I AQL2.5
Powder Residual	<2 mg/glove (ASTM D 5250-06, ASTM D6124-06)	0.1 mg
Biocompatibility
Primary Skin Irritation	Passes (ISO 10993-10: 2010-08-01)	Not a primary skin irritant
Dermal Sensitization	Passes (ISO 10993-10: 2010-08-01)	Not a skin sensitizer
Cytotoxicity	Passes (ISO 10993-5: 2009)	Non-cytotoxicity to L-929 cells

2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes used for each individual non-clinical test (e.g., how many gloves were tested for pinholes, or how many rabbits for skin irritation). The data provenance is implied to be from the manufacturer (Shandong Shangwei Medical Products Co.,Ltd in China) through in-house testing or contracted labs, as these are non-clinical tests used for product compliance. The data is retrospective in the sense that these tests are performed on manufactured product samples.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable. The "ground truth" for these tests are objective measurements against established international and national standards (ASTM, ISO, CFR). There isn't a subjective "expert ground truth" for attributes like glove dimensions or tensile strength.

4. Adjudication method for the test set
Not applicable, as the tests involve objective measurements against predefined standards, not expert adjudication of subjective assessments.

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-powered diagnostic device. It is a medical examination glove.

6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done
Not applicable. This is not an AI-powered diagnostic device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the performance of the gloves is based on objective measurements performed according to validated test methods defined in recognized international and national standards (e.g., ASTM D5250 for dimensions and physical properties, ASTM D5151 for pinholes, ASTM D6124 for powder residual, ISO 10993 for biocompatibility).

8. The sample size for the training set
Not applicable. This is a manufactured product, not an AI model requiring a training set.

9. How the ground truth for the training set was established
Not applicable.

Summary

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

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, with the letters "FDA" in a blue square. Next to that is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

May 14, 2021

Shandong Shangwei Medical Products Co.,Ltd % Chu Xiaoan Official Correspondent Beijing Easy-Link Company Rm. F302 Bldg., 41, Jing Cheng Ya Ju, Courtyard 6 of Southern Dou Ge Zhuang, Chaoyung District Beijing, 100121 China

Re: K210780

Trade/Device Name: Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LYZ Dated: February 8, 2021 Received: March 15, 2021

Dear Chu Xiaoan:

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,

Clarence W. Murray, III, PhD 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

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K210780

Device Name

Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

| Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

510(K) Summary

= "The assigned 510(k) number is: K210780

Premarket Notification [510(k)] Summary

1.0 Submitter:

Submitter's name :	Shandong Shangwei Medical Products Co.,Ltd
Submitter's address :	North Road, Fumin Avenue,Qinghe Street,Caoxian County,Heze City, ShandongProvince, 274400,P.R. China
Phone number:	0086-530-20697110086-530-2069778
Name of contact person:	Ms.Li Hua
Date of preparation :	2021-02-08

2.0 Name of the Device

Device Name:	Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)
Proprietary/Trade name:	Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)
Common Name:	Vinyl Patient Examination Glove
Classification Name:	Non-powdered patient examination glove
Device Classification:	I
Regulation Number:	21 CFR 880.6250
Panel:	General Hospital
Product Code:	LYZ

3.0 Predicate device

Device Name:	Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)
Company name:	Zhang Jia Gang Fengyuan Plastic Product Co. Ltd.
510(K) Number:	K091663

4.0 Device Description:

4.1 How the device functions: Poly Vinyl Chloride (PVC) films form a barrier to prevent contamination between patient and examiner

4.2 Scientific concepts that form the basis for the device The PVC rubber is water tight under normal conditions of use. It's tensile properties cause it to conform to the hand, allowing movements necessary for

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

a medical procedure.

4.3 Physical and performance characteristics such as design, materials and physical properties:

The Poly (vinyl chloride) glove acts as a barrier to prevent contamination between patient and examiner. The glove is manufactured in accordance with the requirements of ASTM D5250 and ASTM D5151.

5.0 Indications for Use Statement:

Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

6.0 Summary of the Technological Characteristics of the Device:

Provided below is the Technological Characteristics Comparison Table that provides a comparison between the subject device and the predicate device.

Characteristics	Standard
Dimension	ASTM D 5250-06(Reapproved 2015).
	Length ≥230mm
	WidthSmall 80-90 mmMedium 90-100mmLarge 100-110mmX large 110-120 mm
	ThicknessFingertip ≥0.05mmPalm ≥0.08mm
	PhysicalProperties
	Tensile strength (Before & After aging) ≥11MPa
	Elongated rate (Before & After aging) ≥300%
Freedom frompinholes	21 CFR 800.20ASTM D5250-06(Reapproved 2015) Passed Standard Acceptance CriteriaASTM D5151-19
Powder Residual	ASTM standard D 5250-06 (Reapproved 2015).and D6124-06(Reapproved 2017)Meets <2mg/glove
Biocompatibility	Primary Skin Irritation in rabbitsISO 10993-10: 2010-08-01PassesUnder the conditions ofthe study, the subjectdevice is not aprimary skin irritant.
	Dermal sensitization in the guinea pigISO 10993-10: 2010-08-01PassesUnder the conditions ofthe study, the subjectdevice is not askin sensitizer.
	The test article was added to L929 cellsmeasured by MTT assayISO 10993-5: 2009PassUnder the conditions ofthis study, the testarticle wasnon-cytotoxicity toL-929 cells

Features & Description	Predicate Device	Subject Device	Result ofComparison
DimensionsWidth	Small 80-90	81-89	82-88	Similar
(mm)	Medium	90-100	93-99	94-98
IL S-2	Large	100-110	102-110	103-109
AQL4.0	X large	110-120	111-1119	114-117
DimensionsThickness(mm)	Finger	≥0.05	0.05-0.10	0.09-0.10	Similar
IL S-2AQL4.0	Palm	≥0.08	0.09-0.13	0.10-0.11
PhysicalProperties	Before aging/after aging				Similar
		Elongation ≥300%	380-410%	350-420%
IL S-2AQL4.0	Tensile Strength≥ 14MPa		16-20 MPa	15-22 MPa
Freedom fromPinholes	Holes atInspection LevelI AQL2.5		Holes atInspection LevelI AQL2.5	Holes atInspection Level IAQL2.5	Same
ResidualPowder	below 2mg ofresidual powder		0.3mg	0.1mg	Similar
Materials used to fabricatethe devices			PVC	PVC	Same
Compare performance datasupporting substantialequivalence		MeetsASTM D5151-06(Reapproved 2011)ASTM D5250-06(Reapproved 2011)ASTM D6124-06(Reaffirmation 2011)	MeetsASTM D5151-19ASTM D5250-06(Reapproved 2015)ASTM D6124-06(Reapproved 2017)		Same
Single Patient Use			Single Patient Use	Single Patient Use	Same
Biocompatibility			Under the conditionsof this study, not anirritant and Under theconditions of thisstudy, not asensitizer.SKIN IRRITATIONDERMAL andSENSITIZATIONSTUDIES Meets ISO10993-10:2002/Amd.1:2006	Under the conditionsof this study, not anirritant and Underthe conditions ofthis study, not asensitizer.SKIN IRRITATIONDERMAL andSENSITIZATIONSTUDIES MeetsISO 10993-10 ThirdEdition 2010-08-01Under the conditionsof this study, the testarticle wasnon-cytotoxicity toL-929 cells.	Similar
Labeling for the legallymarketed device to whichsubstantial equivalence isclaimed.			-Powder Free-Patient ExaminationGlove-Single Use Only- Manufactured For:- Lot	-Powder Free-Patient ExaminationGlove-Single Use Only- Manufactured For:- Lot	Same

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

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

7.0 Summary of Non-Clinical Performance Data:

Non-clinical tests were conducted to verify that the proposed device will meet acceptance criteria for each test. The test results demonstrated that the proposed device met the acceptance criteria found in the following standards below:

ISO 10993-5:2009	Biological Evaluation of Medical Devices - Part 5: TestsFor In Vitro Cytotoxicity
ISO 10993-10:2010	Biological Evaluation of Medical Devices - Part 10: TestsFor Irritation And Skin Sensitization.
ASTM D5151-19	Standard Test Method for Detection of Holes in MedicalGloves.
ASTM D5250-06(Reapproved 2015)	Standard specification for poly (vinyl chloride) gloves formedical application.
ASTM D6124-06(Reapproved 2017)	Standard Test Method for Residual Powder on MedicalGloves

Characteristics	Standard
Dimension	ASTM D 5250-06(Reapproved 2015).
	Length ≥230mm
	Width Small 80-90 mmMedium 90-100mmLarge 100-110mmX large 110-120 mm
	Thickness Fingertip ≥0.05mmPalm ≥0.08mm
	PhysicalProperties	ASTM D 5250-06(Reapproved 2015).Tensile strength (Before & After aging) ≥11MPaElongated rate (Before & After aging) ≥300%
	Freedom frompinholes	21 CFR 800.20 Passed StandardASTM D5250-06(Reapproved 2015) Acceptance CriteriaASTM D5151-19
Powder Residual	ASTM standard D 5250-06 (Reapproved 2015).and D6124-06(Reapproved 2017) Meets <2mg/glove
Biocompatibility	Primary Skin Irritation in rabbits PassesISO 10993-10: 2010-08-01 Under the conditionsof the study, the subjectdevice is not aprimary skin irritant.
	Dermal sensitization in the guinea pig PassesISO 10993-10: 2010-08-01 Under the conditions ofthe study, the subjectdevice is not askin sensitizer.
	The test article was added to L929 cells Passmeasured by MTT assay Under the conditionsISO 10993-5: 2009 of this study, the testarticle wasnon-cytotoxicity toL-929 cells.

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

Summary of Clinical Performance Data: 8.0

Clinical testing is not needed for this device.

9.0 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 predicated device.

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.