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

Device Description

Classified by FDA's General and Plastic Surgery Device panel as Class 1, 21 CFR 880.6250, Powder-Free Nitrile Patient Examination Glove. 80LZA, and meets all requirement of ASTM Standard D6319-10.

AI/ML Overview

This document describes the premarket notification for the "Blue Nitrile Powder-Free Exam Glove" by Shandong Xinshi Medical Products Co., Ltd. The submission aims to demonstrate substantial equivalence to a predicate device.

Here's the breakdown of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criterion	Predicate Device Requirement	Device Performance (Blue Nitrile Powder-Free Exam Glove)
Mechanical Properties
Before Aging: Tensile Strength (Mpa)	Substantially equivalent	Average 28.77 Mpa
Before Aging: Ultimate Elongations (%)	Substantially equivalent	Average 759.23%
After Aging: Tensile Strength (Mpa)	Substantially equivalent	Average 24.00 Mpa
After Aging: Ultimate Elongations (%)	Substantially equivalent	Average 712.31%
Physical Dimensions
Overall Length on Medium Size	Substantially equivalent	Average 231 mm
Width of Palm on Medium Size	Substantially equivalent	Average 95.15 mm
Palm Thickness	Substantially equivalent	Average 0.08 mm
Finger Thickness	Substantially equivalent	Average 0.09 mm
Barrier Integrity
Free of Pinhole	Meets ASTM D5151-06 (AQL 2.5)	Testing result indicates pinhole were found less than two pieces gloves out of 125 pieces gloves. AQL 2.5 is met.
Material/Processing Residuals
Residue Powder	Meets ASTM D6124-06 (< 2 mg per glove)	Testing result indicates the weight of all types of residual or powder on finished powder-free gloves as < 2 mg per glove and there is no defect glove found according to ASTM D6124-06.
Biocompatibility
Primary Skin Irritation	Under the conditions of the study, not an irritant	Under the conditions of the study, not an irritant
Dermal Sensitization	Under conditions of the study, not a sensitizer	Under conditions of the study, not a sensitizer

Study Details:

For medical gloves, the "study" typically refers to several non-clinical tests performed according to recognized standards to ensure the device performs as intended and is safe for use.

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

Pinhole Test (ASTM D5151-06): The document states "less than two pieces gloves out of 125 pieces gloves." This indicates that a sample of 125 gloves was used for this particular test.
Residue Powder Test (ASTM D6124-06): While a specific sample size isn't explicitly stated, the method implies testing on a sample of gloves to determine residual powder content.
Physical and Dimensions Testing: "Inspection Level S-2. AQL 2.5" is mentioned, which refers to sampling plans defined in standards like ISO 2859-1. The exact sample size would depend on the lot size from which the samples were drawn.
Data Provenance: The tests were conducted by Shandong Xinshi Medical Products Co., Ltd. in China, or laboratories commissioned by them. This is retrospective data from product testing for regulatory submission.

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

This information is not applicable in this context. The "ground truth" for medical gloves is established by objective measurements against recognized performance standards (like ASTM standards) and validated test methods, not by expert consensus or interpretation of complex data like medical images. The test results themselves directly demonstrate compliance with the defined criteria.

4. Adjudication Method for the Test Set:

This information is not applicable. Adjudication methods like 2+1 or 3+1 are typically used for clinical studies involving human interpretation or subjective assessments. For objective performance testing of a physical medical device like a glove, the results of the specified test methods are directly compared to the acceptance criteria.

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 is not applicable. This question addresses AI/diagnostic imaging performance, which is entirely outside the scope of evaluating a medical glove.

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

This is not applicable. This question addresses AI algorithm performance.

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

The "ground truth" for the performance of the Blue Nitrile Powder-Free Exam Glove is based on objective measurements obtained through standardized laboratory test methods (e.g., tensile strength, elongation, pinhole detection, residual powder measurement, skin irritation tests) as defined by ASTM standards (specifically ASTM D6319-10, D5151-06, and D6124-06) and other relevant regulations (e.g., FDA 1000 ml. Water Fill Test).

8. The Sample Size for the Training Set:

This information is not applicable. The concept of a "training set" is relevant for machine learning algorithms. For a physical medical device, there is no "training set" in this sense. The manufacturing process is designed to consistently produce gloves meeting specifications, which is then validated through quality control and regulatory testing.

9. How the Ground Truth for the Training Set was Established:

This information is not applicable for the reasons stated in point 8.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

August 8, 2014

Shandong Xinshi Medical Products Co, Ltd. Mr. Ray Zhou Official Correspondent Basic Medical Industries, Inc. 12390 East End Avenue Chino. CA 91710

Re: K133325

Trade/Device Name: Blue Nitrile Powder-Free Exam Glove Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: June 30, 2014 Received: July 7, 2014

Dear Mr. Zhou:

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.

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Page 2 - Mr. Zhou

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 (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); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Tejashri Purohit-Sheth, M.D.

Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR

Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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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 on last page.

510(k) Number (if known) K133325

Device Name

Blue Nitrile Powder-Free Exam Glove

Indications for Use (Describe)

A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner's hands of 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)

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) (Signalure)

Sreekanth Gutala -S

Digitally signed by Sreekanth Gutala -S DN: c=US, o=U.S. Government, ou=HHS, ou=FDA, ou=People, 0.9.2342.19200300.100.1.1=2000540490, cn=Sreekanth Gutala -S Date: 2014.08.07 08:11:31 -04'00'

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510 (K) SUMMARY

This summary of 510(K) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and 21CFR 807.92.

1. Submitter's Identification:

Shandong Xinshi Medical Products Co., Ltd. No. 566 Baiyun Road, Hanting Development Zone, Weifang, Shandong, China

Contact Person: Ray Zhou Tel: 909-548-4828 Fax: 909-548-4807 Email: ravzhou@basicmedical.com

Date summary prepared: August 7, 2014

2. Name of the Device:

Blue Nitrile Powder-Free Exam Glove

Proprietary/trade name of the Device: 3.

Blue Nitrile Powder-Free Exam Glove

Common name of the Device: -1.

Blue Nitrile Powder-Free Exam Glove

న. Classification name of the Device:

Blue Nitrile Patient Exam glove: Class I. Non-Sterile Powder-Free Patient Examination Gloves.

Predicate Device Information: 6.

Tangshan Zhonghong Pulin Group Co., Ltd. Synthetic Nitrile Patient Examination Gloves - Powder Free (K082598)

7. Device Description:

Classified by FDA's General and Plastic Surgery Device panel as Class 1, 21 CFR 880.6250, Powder-Free Nitrile Patient Examination Glove. 80LZA, and meets all requirement of ASTM Standard D6319-10.

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જં Intended 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 (21CFR 880.6250)

9. Comparison to Predicate Devices:

Shandong Xinshi Medical Products Co., Ltd. Blue Nitrile Powder-Free Exam Glove are substantially equivalent in safety and effectiveness to the Tangshan Zhonghong Pulin Group Co., Ltd. Powder –Free Nitrile Patient Examination Gloves.

1 (). Discussion of Non-Clinical tests performed for Determination of Substantial Equivalence are as follows:

The standards used for Shandong Xinshi Medical Products Co., Ltd. glove production are based on ASTM-D-6319-10. All testing meets requirements for Physical and Dimensions Testing conducted on gloves. Inspection Level S-2. AQL 2.5.

The FDA 1000 ml. Water Fill Test was also conducted with samplings of AQL 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.

There are no special labeling claims and we do not claim our gloves as hypoallergenic is conducted to insure that our gloves meet our "powder-free" claims (contain no more than 2 mg powder per glove).

11. Discussion of Clinical Tests Performed:

Not Applicable - There is no hypoallergenic claim.

l 2. Conclusions:

Shandong Xinshi Medical Products Co., Ltd. Blue Nitrile Powder-Free Exam Glove conform fully to ASTM-D-6319-10 standard as well as applicable 21 CFR references, and, meets pinhole FDA requirements, biocompatibility requirements and labeling claims. The conclusion drawn from the nonclinical test demonstrates that the device is as safe, as effective, and performs as well as or better than the legally marketed predicate device.

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Side-by-Side Comparison of Intended Use, Design, Material, Physical,

	Proposed Device	Predicate Device (K082598)
Description	Shandong Xinshi MedicalProducts Co., Ltd. Synthetic, BlueNitrile Powder-Free Exam Glove	Tangshan Zhonghong Pulin GroupCo., Ltd. Powder Free NitrilePatient Examination Gloves
Indication for Use	Disposable device intended formedical purposes that is worn onthe examiner's hand or finger toprevent contamination betweenpatient and examiner	Disposable device intended formedical purposes that is worn onthe examiner's hand or finger toprevent contamination betweenpatient and examiner
Basic Design	A garment covering the hand andwrist area. Have separate sheathsor openings for each finger andthe thumb.	A garment covering the hand andwrist area. Have separate sheaths oropenings for each finger and thethumb.
Materials Used	Nitrile Latex (NBR)Sulfur Accelerator, ZDBC	Nitrile Latex (NBR)Sulfur Accelerator, ZDBC
Single Use	Yes	Yes
Size	S,M,L,XL	Information Unavailable
Sterile	Not sterile	Not sterile
Before Aging:Tensile,Strength(Mpa) andUltimate Elongations	Average Tensile Strength (Mpa):28.77Average Ultimate Elongations:759.23%	Substantially equivalent
After Aging: TensileStrength(Mpa) andUltimate Elongations	Average Tensile Strength (Mpa):24.00Average Ultimate Elongations:712.31%	Substantially equivalent
Overall Length onMedium Size	Average 231 mm	Substantially equivalent
Width of Palm onMedium Size	Average 95.15 mm	Substantially equivalent
Palm Thickness	Average 0.08 mm	Substantially equivalent
Finger Thickness	Average 0.09 mm	Substantially equivalent
Free of Pinhole	According to ASTM D5151-06.Testing result indicates pinholewere found less than two piecesgloves out of 125 pieces gloves.AQL 2.5 is met.	Meets ASTM D5151-06
Residue Powder	According to ASTM D6124-06 Standard Test Method for Residual Powder on Medical gloves for the determination of residual powder content. Testing result indicates the weight of all types of residual or powder on finished powder-free gloves as < 2 mg per glove and there is no defect glove found according to ASTM D6124-06.	Meets ASTM D6124-06
Primary SkinIrritation	under the conditions of the study, not an irritant	under the conditions of the study. not an irritant
Dermal Sensitization	under conditions of the study, not a sensitizer	under conditions of the study, not a sensitizer
Summary ofcomparison	Shandong Xinshi Medical Products Co., Ltd. Synthetic, Blue Nitrile Powder-Free Exam Glove (subject device) and Tangshan Zhonghong Pulin Group Co., Ltd. Powder Free Nitrile Patient Examination Gloves (predicate device) are substantially equivalent in all technological characteristics, including tensile strength, ultimate elongations size, thickness, residual powder and pinhole.

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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.