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

Device Description

A Powder-free Clear Vinyl Patient Examination Gloves is a disposable device intended for medical purposes that is worn upon the examiner's hands or finger to prevent contamination between patient and examiner (21CFR 880.6250). Our Powder-free Clear Vinyl Patient Examination Gloves do not contain any UPS powder according to the results of testing conducted on the gloves. The residual powder testing is conducted per standards of ASTM D-6124-06, which demonstrates that the powder free glove is less than 2mg/pc. Classified by FDA's General and Plastic Surgery Device panel as Class I, 21 CFR 880.6250, Powder-Free Vinyl Patient Examination Glove, LYZ, and meets all requirement of ASTM Standard 5250-06.

AI/ML Overview

This document is a 510(k) Pre-market Notification for a medical device: Powder-free Clear Vinyl Patient Examination Gloves.

Here's an analysis of the acceptance criteria and study information provided, focusing on the requested elements:

Acceptance Criteria and Device Performance

The document does not explicitly state "acceptance criteria" in a separate section with pass/fail thresholds against which the device is formally judged. Instead, it presents a comparison of the proposed device's characteristics and performance against a legally marketed predicate device (K142703). The "Comparison Conclusion" column often states "Similar," implying that meeting or being comparable to the predicate's performance constitutes the acceptance for substantial equivalence.

Based on the "Technological Characteristic Comparison" table, here's a representation of the implicit acceptance criteria and the reported device performance:

Characteristic	Implicit Acceptance Criteria (based on predicate K142703)	Reported Proposed Device Performance (K173078)	Comparison Conclusion (as stated)
Product Name	Similar to Hebei Grandeast Plastic Products Co., Ltd. Glide-On Vinyl Examination Gloves	Yongsheng Medical Products Co., Ltd Powder-free Clear Vinyl Patient Examination Gloves	Similar
Product Code	LYZ	LYZ	Similar
Intended Use	Disposable device for medical purposes, worn on hand/finger to prevent contamination	Disposable device for medical purposes, worn on hand/finger to prevent contamination	Similar
Length on Large Size	>230 mm	Average over 232.23mm	Similar
Width of Palm on Large Size	>105 mm	Average 95mm	Similar
Palm Thickness	0.10 mm	Average 0.095 mm	Similar
Fingertip Thickness	0.10 mm	Average 0.09 mm	Similar
Residual Powder	< 2 mg per glove (per ASTM D6124-06)	< 2 mg per glove (per ASTM D6124-06)	Similar
Pinhole Results	Comply with ASTM D5151-06 (AQL 2.5)	Comply with ASTM D5151-06 (AQL 2.5)	Similar
Primary Skin Irritation	Not an irritant	Not an irritant	Similar
Before Aging: Tensile Strength	>= 11 Mpa	Average 17.4 Mpa	Similar
Before Aging: Ultimate Elongation	>= 300%	Average 519%	Similar
After Aging: Tensile Strength	>= 11 Mpa	Average 14.96 Mpa	Similar
After Aging: Ultimate Elongation	>= 300%	Average 480.76%	Similar
Dermal Sensitization	Not a sensitizer	Not a sensitizer	Similar

"The Study That Proves the Device Meets the Acceptance Criteria":

The document describes non-clinical tests performed to demonstrate substantial equivalence to the predicate device. These tests align with recognized standards for patient examination gloves.

Sample size used for the test set and the data provenance:
- Length on Large Size: The specific sample size isn't explicitly stated for the "Average over 232.23mm" measurement.
- Width of Palm on Large Size: The specific sample size isn't explicitly stated for the "Average 95mm" measurement.
- Palm Thickness: The specific sample size isn't explicitly stated for the "Average 0.095 mm" measurement.
- Fingertip Thickness: The specific sample size isn't explicitly stated for the "Average 0.09 mm" measurement.
- Residual Powder: Not explicitly stated, but the testing was conducted per ASTM D6124-06.
- Pinhole Results: The test set for pinhole detection was 125 gloves, with the requirement that fewer than two pieces of gloves out of 125 have pinholes to meet AQL 2.5. This seems to be a specific sample size.
- Biocompatibility (Primary Skin Irritation, Dermal Sensitization): The sample size for these studies is not specified in the provided summary.
- Tensile Strength and Ultimate Elongation (Before and After Aging): The specific sample size used for these mechanical properties tests is not explicitly stated.
- Water Fill Test: "Samplings of AOL 2.5, Inspection Level I" was used, but the specific number of gloves isn't given.
- Data Provenance: The data appears to be prospective testing conducted on the Yongsheng Medical Products Co., Ltd gloves. The "country of origin" for these tests is implicitly China, as the submitter is based in China.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This device is an examination glove, and its performance is evaluated through objective physical, chemical, and biological tests governed by established standards (e.g., ASTM). There is no mention of human expert interpretation or subjective ground truth establishment for these types of tests.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable, as expert adjudication is not relevant for the objective performance tests of an examination glove.
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 document pertains to a physical medical device (examination gloves), not an AI imaging or diagnostic algorithm.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is not an algorithm. The tests are for the physical properties of the glove.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): The "ground truth" for the performance characteristics of the gloves is established by the methods, specifications, and acceptable limits defined in the referenced industry standards, primarily ASTM D5250-06 for general requirements, ASTM D6124-06 for residual powder, and ASTM D5151-06 for pinhole defects. Biocompatibility tests followed standard protocols to determine irritation and sensitization.
The sample size for the training set: Not applicable. This is not a machine learning or AI device.
How the ground truth for the training set was established: Not applicable.

Summary

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

Image /page/0/Picture/0 description: The image contains the logos of the U.S. Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized caduceus. To the right of it is the FDA logo, with the acronym "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" and "ADMINISTRATION" in blue text.

March 9, 2018

Yongsheng Medical Products Co., Ltd % Melo Zhang Official Correspondent Intco Medical Industries, INC. 805 Barrington Ave Ontario, California 91764

Re: K173078

Trade/Device Name: Powder-free Clear Vinyl Patient Examination Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: Class I Product Code: LYZ Dated: January 29, 2018 Received: February 2, 2018

Dear Melo Zhang:

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. 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 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);

{1}------------------------------------------------

K173078

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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Michael J. Ryan -S

for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known)

K173078

Device Name

Powder-free Clear Vinyl Patient Examination Gloves

Indications for Use (Describe)

A patient examination glove is a disposable device intended for medical purposes that is worn upon 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)

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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 K173078

1. Submitter's Identification:
  Yongsheng Medical Products Co., Ltd No. 4519 Qingzhou Road Shao De Industrial Park China Contact Person: Melo Zhang Official Correspondent

Date summary prepared: March 6, 2018

1. Name of the Device:
  Yongsheng Medical Products Co., Ltd Powder-free Clear Vinyl Patient Examination Gloves
1. Trade Name
  Yongsheng Medical Products Co., Ltd Powder-free Clear Vinyl Patient Examination Gloves
1. Predicate Device Information:
  Powder-free PVC Vinyl Exam Gloves Hebei Grandeast Plastic Products Co.,Ltd. K 142703

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

5. Device Description:

1. Indication for Use:
  A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner's hands or finger to prevent contamination between patient and examiner.
1. Technological Characteristic Comparison:

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

DeviceCharacteristics	Proposed Device	Predict Device(K142703)	ComparisonConclusion
Product Name	Yongsheng Medical ProductsCo., LtdPowder-free Clear VinylPatient Examination Gloves	Hebei Grandeast PlasticProducts Co., Ltd.Glide-On VinylExamination Gloves	Similar
Product Code	LYZ	LYZ	Similar
Intended Use	Disposable device intendedfor medical purposes that isworn on the examiner's handor finger to preventcontamination betweenpatient and examiner	Disposable device intended formedical purposes that is wornon the examiner's hand orfinger to prevent contaminationbetween patient and examiner	Similar
Length on LargeSize	Average over 232.23mm	>230 mm	Similar
Width of Palm onLarge Size	Average 95mm	>105 mm	Similar
Palm Thickness	Average 0.095 mm	0.10 mm	Similar
FingertipThickness	Average 0.09 mm	0.10 mm	Similar
Residual Powder	According to ASTM D6124-06 Standard Test Method forResidual Powder on Medicalgloves for the determinationof residual powder content.Testing result indicates theweight of all types of residualor powder on finishedpowder-free gloves as < 2 mgper glove and there is nodefect glove found accordingto ASTM D6124-06.	< 2 mg per glove	Similar
Pinhole Results	According to ASTM D5151-06, Testing result indicatespinhole were found less thantwo pieces gloves out of 125gloves. AQL 2.5 is met.	Comply with ASTM D5151-06,Testing result indicates pinholewere found less than two piecesgloves out of 200 gloves. AQL2.5 is met.	Similar

Table 7-2. Side-by-Side Comparison of Intended Use, Design, Material, Physical, Biocompatibility, and Performance Testing

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

BiocompatibilityResult: PrimarySkin Irritation	Under the conditions of thestudy, the subject device isnot an irritant	Under the conditions of thestudy, the subject device is notan irritant	Similar
Before Aging:Tensile Strength(Mpa) andUltimateElongations	Average Tensile Strength(Mpa): 17.4Average UltimateElongations: 519%	Average Tensile Strength(Mpa): 11Average Ultimate Elongation:>300%	Similar
After Aging:Tensile Strength(Mpa) andUltimateElongations	Average Tensile Strength(Mpa): 14.96Average UltimateElongations:480.76%	Average Tensile Strength(Mpa): 11Average Ultimate Elongation>300%	Similar
DermalSensitization	Under the conditions of thestudy, the subject device isnot a sensitizer	Under the conditions of thestudy, the subject device is nota sensitizer	Similar
Summary	Yongsheng Medical Products Co., Ltd Powder-free Clear Vinyl PatientExamination Gloves are similar to the predicate, K142703.

1. Discussion of Non-Clinical tests performed for Determination of Substantial Equivalence are as follows:
  The standards used for Yongsheng Medical Products Co., Ltd glove production is based on ASTM-D5250-06. All testing meets requirements for Physical and Dimensions Testing conducted on gloves, Inspection Level S-2, AQL 2.5.

The 1000ml. Water Fill Test was also conducted with samplings of AOL 2.5, Inspection Level I, meeting these requirements, Primary Skin irritation and Skin Sensitization (allergic contact dermatitis) testing was conducted with results showing no primary skin irritant or sensitization reactions.

Our gloves meet our "powder-free" claims and contain no more than 2 mg powder per glove.

1. Conclusions:
  The conclusions drawn from the nonclinical and clinical tests that demonstrate that the subject device is as safe, as effective, and performs as well as the predict 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.