A powder free patient examination glove is a disposable device intended for medical purposes that is worn on the examiners hand or finger to prevent contamination between patient and examiner.

Device Description

Chienmax Vietnam Co. Ltd Powder Free Blue Nitrile Patient Examination Gloves are Class I disposable device which are made up of nitrile synthetic rubber , intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner and which meets all of the requirements of ASTM standard D6319 00a (2005).

AI/ML Overview

This document describes the Chienmax Vietnam Co. Ltd Powder-free Blue Nitrile Patient Examination Gloves and their substantial equivalence to predicate devices, rather than a clinical study evaluating the performance of an AI-powered medical device. Therefore, many of the requested categories are not applicable.

Here's an analysis based on the provided text, focusing on the available information:

1. Table of acceptance criteria and the reported device performance

The acceptance criteria for the Chienmax Vietnam Co. Ltd Powder-free Blue Nitrile Patient Examination Gloves are based on meeting the requirements of ASTM standard D6319-00a (2005). The reported device performance indicates that the gloves meet these requirements.

Characteristic and parameters	Acceptance Criteria (from ASTM D6319-00a and predicate)	Reported Device Performance (Chienmax)
Product Code	LZA	LZA
Intended Use	Prevent contamination between patient and examiner	Prevent contamination between patient and examiner
Width (size medium)	Approximately 89-98 (based on predicates)	95
Overall length	Approximately 240 (based on predicates)	244
Palm thickness	Min 0.08 - 0.12 (based on predicates)	0.113
Finger thickness	Min 0.08 - 0.148 (based on predicates)	0.138
Tensile strength pre aging min	15 - 22 (based on predicates)	16.78
Tensile strength after aging min	14 - 23.6 (based on predicates)	17.40
Ultimate elongation pre aging min	500 - 679.4 (based on predicates)	510
Ultimate elongation after aging	500 - 767.4 (based on predicates)	555
Biocompatibility	Yes (based on predicates)	Yes
Duration of biocompatibility	Limited (based on predicates)	Limited
Skin irritation test	Passes	Passes
Dermal sensitization	Passes	Passes
Residual powder test	Passes	Passes
Labeling	Identical to predicates (except for minor differences)	Minor Difference (from predicates)
Dermal Sensitization Test	Passes (implicit in biocompatibility)	Passes
Primary Skin irritation	Passes (implicit in biocompatibility)	Passes
Permeation testing per ASTM D 6978-05	Passes	Passes
Iodine Test	Passes	Passes
Tensile strength	Meets ASTM D6319-00a requirements	Gloves meets the requirements of ASTM D6319-00a.
Barrier strength	Meets ASTM D6319-00a requirements	Gloves meets the requirements of ASTM D6319-00a.
Pinholes (AQL)	AQL 2.5 (from ASTM D6319-00a)	AQL 2.5 (Implicitly met as per "All testing meets requirements...")
Inspection level	S-2, AQL 4.0 (Physical specifications and dimensions)	S-2, AQL 4.0 (Implicitly met as per "All testing meets requirements...")

2. Sample size used for the test set and the data provenance

The document mentions "Inspection level S-2, AQL 4.0, pinholes at AQL 2.5" for physical specifications and dimensions. This refers to acceptance sampling plans, but does not explicitly state the sample sizes used for each specific test. The data provenance is not specified beyond the fact that the manufacturer is in Vietnam. Given the context of a 510(k) summary for a glove, the testing would be prospective, conducted on manufactured batches of the device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This is for a physical device (patient examination gloves) tested against established physical and chemical standards, not an AI device requiring expert ground truth for interpretation.

4. Adjudication method for the test set

Not applicable for this type of device and testing. The tests involve objective measurements and pass/fail criteria based on ASTM 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 device.

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

Not applicable. This is not an AI device.

7. The type of ground truth used

The "ground truth" for this device is based on established industry standards (ASTM D6319-00a) for physical properties and performance (tensile strength, elongation, barrier strength, etc.), as well as biocompatibility testing to ensure safety (skin irritation, dermal sensitization).

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device that requires a training set.

9. How the ground truth for the training set was established

Not applicable.

Summary

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CHIENMAX VIETNAM CO.,LTD

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K103675

KM 8, PHAM VAN DONG ROAD, HAI THANHDOUNG KINH DISTRICT HAI PHONG, HAI PHONG, TAHNH PHO, 18671, VIETNAM

OCT - 3 2011

TEL:84-313632888 FAX: 84-31336288

EXHIBIT #3

510(k) Summary

This summary of 5l0(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.

Date: August 25, 2011

1. Applicant:

Chienmax Vietnam Co. Ltd Km 8, Pham Van Dong Road, Hai Thanhdoung Kinh Districthai Phong, Hai Phong, Tahnh Pho, 18671, Vietnam

2. Manufacturer: Chienmax Vietnam Co. Ltd Km 8, Pham Van Dong Road,

Hai Thanhdoung Kinh Districthai Phong, Hai Phong, Tahnh Pho, 18671, Vietnam

3. Submitter:

Mr. Jigar Shah Official Correspondent for Chienmax Vietnam Co. Ltd

4. Address:

mdi Consultants, Inc. 55 Northern Blvd., Suite 200 Great Neck, New York 11021 Tel: 516-482-9001 Fax: 516-482-0186 Jigar@mdiconsultants.com

1. Trade/proprietary Name: Chienmax Vietnam Co. Ltd Powder-free Blue Nitrile Patient Examination Gloves.
Common Names: 6. POWDER-FREE Patient Examination Glove
1. Classification name: Device Class I, Patient examination glove (21 CFR 880.6250, product code LZA)

8. Predicate Devices:

Sunmax Vietnam Co. Ltd Powder free Nitrile Patient Examination Gloves. . (K101870)

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ULTRAWIN SDN BHD Non-Sterile Powder Free Nitrile Examination Gloves (K . 090828)
PT. MAHAKARYA INTI BUANA Powder Free Black Nitrile Examination gloves. . (K090464)

9. Device Description:

10. Intended Use:

A powder free patient examination glove is a disposable device intended for medical purposes that is worn on the examiners hand or finger to prevent contamination between patient and examiner.

11. Substantial Equivalence Discussion:

A powder free patient examination glove is substantially equivalent to the predicate devices.

Characteristicand parameters	ChienmaxVietnam Co.,LTD PowderFree Blue NitrileExaminationGlove(New Device)	Sunmax VietnamCo. Ltd Powderfree Nitrile PatientExaminationGloves. (K101870)	ULTRAWINSDN BHDNon-SterilePowder FreeNitrileExaminationGloves(K 090828)	PT.MAHAKARYA INTIBUANAPowder FreeBlack NitrileExaminationgloves.(K090464)	SEComparison
Product Code	LZA	LZA	LZA	LZA
Intended Use	A patientexaminationgloves is adisposable deviceintended formedical purposethat is wornon the examiner'shand or fingers topreventcontaminationbetween patientand examiner.	A patientexamination glovesis a disposabledevice intended formedical purposethat is wornon the examiner'shand or fingers topreventcontaminationbetween patient andexaminer.	A patientexaminationgloves is adisposable deviceintended formedical purposethat is worn onthe examiner'shand or fingers topreventcontaminationbetween patientand examiner.	A powder-freepatientexaminationglove is adisposabledevice intendedfor medicalpurposes that isworn on theexaminer's handor finger topreventcontaminationbetween patientand examiner.	SE
Width (sizemedium)	95	89	93-98	97.7	MinorDifference

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verall length	244	240	240	240.9	MinorDifference
Palm thickness	0.113	0.12	Min 0.08	0.109	MinorDifference
Finger thickness	0.138	0.12	Min 0.08	0.148	MinorDifference
Tensile strengthpre aging min	16.78	22	15 - 21	18.8	MinorDifference
Tensile strengthafter aging min	17.40	23.6	14-22	21.3	MinorDifference
Ultimateelongation preaging min	510	500	550 - 630	679.4	MinorDifference
Ultimateelongation afteraging	555	500	520 - 610	767.4	MinorDifference
MeetsBiocompatibility	yes	Yes	Yes	Yes	SE
Duration of bio-compatibility	Limited	Limited	Limited	Limited	SE
Skin irritation test	Passes	Passes	Passes	Passes	SE
Dermalensitization	Passes	Passes	Passes	Passes	SE
Residual powdertest	Passes	Passes	Passes	Passes	SE
Labeling	Identical	Identical	NA	NA	MinorDifference

12. Summary of Testing:

	Test	Results
a.	Dermal Sensitization Test	Passes
b.	Primary Skin irritation	Passes
c.	Permeation testing per ASTM D 6978-05	Passes
d.	Iodine Test	Passes
e.	Tensile strength	Gloves meets the requirements ofASTM D63 19-00a.
f.	Barrier strength	Gloves meets the requirements ofASTM D63 19-00a.

The standards used by Chienmax Vietnam Co. Ltd to determine substantial equivalence are based on ASTM D 631900a-2005. All testing meets requirements for physical specifications and dimensions conducted on gloves, Inspection level S-2, AQL 4.0, pinholes at AQL 2.5

There are no special labeling claims and we do not claim our gloves to be hypoallergenic.

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13. Conclusion:

Based on the nonclinical tests performed the Chienmax Vietnam Co. Ltd Powder-free Blue Nitrile Examination Glove is as safe, as effective and performs at least as safely and effectively as the legally marketed predicate devices.

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

Chienmax Vietnam Company, Limited C/O Mr. Jigar Shah Official Correspondent MDI Consultants, Incorporated 55 Northern Boulevard, Suite 200 Great Neck, New York 11021

OCT - 3 2011

Re: K103675

Trade/Device Name: Chienmax Vietnam Company, Limited Powder Free Blue Nitrile Patient Examination Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: September 20, 2011 Received: September 22, 2011

Dear Mr. Shah:

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 enners. 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: CDRF; does not evaluate information related to contract liability warranties. We remind you, fovever, 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 89%. In this addition, FDA may publish further announcements concerning your device in the Fight first Register.

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Page 2 - Mr. Shah

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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 offelire number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours.

Cintron
Anthony D. Weiner, P.C. 160 Broadway

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure ·

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Attachment 1

EXHIBIT #1

Indications for Use

510(k) Number (if known): K103675

Applicant: Chienmax Vietnam Co. Ltd

Device Name: Chienmax Vietnam Co. Ltd Powder Free Blue Nitrile Patient Examination Gloves.

Indications for Use:

A powder free patient examination glove is a disposable device intended for medical purposes that is worn on the examiners hand or finger to prevent contamination between patient and examiner.

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use X (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

AND/OR

Shula R. Murphy, MD, John F. Chrocien-Williams
(Division Sign-Off)

Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K:103675

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.