A powder free patient examination glove (Tested for Use with Chemotherapy Drugs) is a disposable device intended for medical purposes that is worn on the examiners hand or finger to prevent contamination between patient and examiner. These gloves are not intended to be used as a chemical barrier.

Device Description

Sunmax Enterprise Shanghai Co Powder free blue Nitrile Examination Glove is a class II device having product code 80LZA. It is a disposable device that meets all requirements of ASTM D 631900a-05 and is tested with chemotherapy drugs.

AI/ML Overview

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The device is a patient examination glove, and its performance is assessed against established ASTM standards and specific physical characteristics. The document doesn't explicitly state "acceptance criteria" as a distinct section but lists characteristics and test results that imply acceptance based on meeting these values or passing these tests.

Characteristic/Test	Acceptance Criteria (Implied by Predicate/Standard)	Reported Device Performance (Sunmax Device)
Physical Dimensions (Size Medium)
Width (size medium)	e.g., ~92mm (based on predicates)	89mm
Overall length	240mm (based on predicates)	240mm
Palm thickness	e.g., ~0.17mm (based on predicates)	0.12mm
Finger thickness	e.g., ~0.18mm (based on predicates)	0.12mm
Mechanical Properties
Tensile strength pre-aging min	21mpa (based on predicates for similar devices)	18mpa
Tensile strength after-aging min	16mpa (based on predicates for similar devices)	18mpa
Ultimate elongation pre-aging min	500 (based on predicates for similar devices)	600
Ultimate elongation after-aging min	500 (based on predicates for similar devices)	570
Biocompatibility
Meets Biocompatibility	Yes (based on predicates)	Yes
Duration of biocompatibility	Limited (based on predicates)	Limited
Skin irritation test	Passes	Passes (Result of Primary Skin Irritation Test)
Dermal sensitization	Passes	Passes (Result of Dermal Sensitization Test)
Barrier Performance
Residual powder test	Passes	Passes
Permeation testing per ASTM D 6978-05	Passes (Performance against specific chemotherapy drugs)	Passes (Table of breakthrough times for 9 chemo drugs)
Iodine Test	Passes	Passes
Barrier strength	Meets requirements of ASTM D6319-00a	Meets the requirements of ASTM D6319-00a
General Glove Requirements
Meets ASTM D 6319-00a-05 (overall standard)	Meets requirements	Gloves meets the requirements of ASTM D6319-00a (for tensile strength) and overall testing meets requirements
Inspection level, AQL (pinholes)	S-2, AQL 4.0, AQL 2.5 (pinholes)	(Implied by adherence to ASTM D6319-00a standards)

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

Sample Size: The document does not specify a separate "test set" sample size for the various tests. It generally refers to testing being conducted to meet ASTM standards. For pinholes and general inspection, it mentions "Inspection level S-2, AQL 4.0, pinholes at AQL 2.5," which are statistical sampling plans defined within the ASTM standard, but not explicit sample numbers.
Data Provenance: Not explicitly stated. The manufacturer is in Shanghai, China, so it's most likely that the testing was performed there. It's retrospective in the sense that the data is presented as a summary of completed tests for the 510(k) submission.

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

Not applicable. This device is a medical glove, and "ground truth" as typically defined for diagnostic or AI-driven devices (e.g., expert consensus on images, pathology reports) is not relevant. The performance is assessed through standardized physical, chemical, and biological tests.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods like "2+1" are used for expert review where there might be disagreement, usually for image interpretation or similar qualitative assessments. For material property testing, the results are quantitative and objective measurements or pass/fail criteria against a standard.

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-driven device or a diagnostic device where human readers would be involved in interpretation.

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

Not applicable. This is a physical medical device (glove), not an algorithm or software.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established by:

ASTM Standard Specifications: Specifically, ASTM D 6319-00a-05 for physical properties and dimensions.
Permeation Testing per ASTM D 6978-05: For chemotherapy drug resistance, the "ground truth" is whether the glove prevents breakthrough for a specified duration according to this standard.
Biocompatibility Testing: "Passes" results for dermal sensitization and primary skin irritation tests establish the ground truth for biocompatibility.

8. The Sample Size for the Training Set

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

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

Not applicable. No training set is involved.

Summary

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K090336

EXHIBIT #3

510(k) Summary

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

1. Applicant:

Sunmax Enterprise Shanghai Co., Ltd No.2 New Industrial Area, Zhu Hang Zhen Jin Shan Xian, Shanghai, China

JUL - 1 2009

Manufacturer: Sunmax Enterprise Shanghai Co., Ltd No.2 New Industrial Area, Zhu Hang Zhen Jin Shan Xian, Shanghai, China

3. Submitter:

Mr. Jigar Shah Official Correspondent for Sunmax Enterprise Shanghai 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

5. Trade/proprietary Name:

Sunmax Enterprise Shanghai Co Powder free Blue Nitrile Patient Examination Glove tested with chemotherapy drugs.

1. Common Names: POWDER-FREE Patient Examination Glove

7. Classification name: Patient Examination Glove

1. Classification number: 21 CFR 880.6250

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9. Device Description:

10. Intended Use:

11. Substantial Equivalence Discussion:

A powder free patient examination glove (Tested for Use with Chemotherapy Drugs) is substantially equivalent to the predicate devices.

Characteristicand parameters	SunmaxEnterpriseShanghai Co.,LTD (NewDevice)	Shanghai ChinaStar Corp(K) 071072	MEDLINEINDUSTRIES,INC(K) 040841	SubstantialEquivalence(SE)
Product Code	LZA	LZA	LZA
Intended Use	A powder freepatientexaminationglove (Testedfor Use withChemotherapyDrugs) is adisposabledevice intendedfor medicalpurposes that isworn on theexaminers handor finger topreventcontaminationbetween patientand examiner.These glovesare not intendedto be used as achemical barrier	A powder freepatientexaminationglove (Tested forUse withChemotherapyDrugs) is adisposable deviceintended formedical purposesthat is worn onthe examinershand or finger topreventcontaminationbetween patientand examiner.These gloves arenot intended to beused as achemical barrier	MedlinePowder-FreeBlue NitrileExaminationGloves (Testedfor Use withChemotherapyDrugs) is adisposabledevice intendedfor medicalpurposes that isworn on theexaminer's handor finger topreventcontaminationbetween patientand examiner.	SE
Width (sizemedium)	89mm	92mm	92mm	Minordifference

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Overall length	240mm	240mm	240mm	SE
Palm thickness	0.12mm	0.17mm	0.17mm
Finger thickness	0.12mm	0.18mm	0.18mm
Tensile strengthpre aging min	18mpa	21mpa	21mpa
Tensile strengthafter aging min	18mpa	16mpa	16mpa
Ultimateelongation preaging min	600	500	500	Minordifference
Ultimateelongation afteraging min	570	500	500
MeetsBiocompatibility	Yes	Yes	Yes
Duration of bio-compatibility	Limited	Limited	Limited
Skin irritation test	Passes	Passes	Passes	SE
Dermalsensitization	Passes	Passes	Passes
Residual powdertest	Passes	Passes	Passes

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 Sunmax Enterprise Shanghai Co 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:

Powder free Blue Nitrile Patient Examination Glove tested with chemotherapy drugs performance was equivalent to any other conventional method evaluated. Our evaluation concluded that our device raises no new issues of Safety and effectiveness.

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a representation of human figures.

Public Health Service

JUL - 1 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Sunmax Enterprise Shanghai Company, Limited C/O Mr. Jigar Shah mdi Consultants, Incorporated 55 Northern Boulevard, Suite 200 Great Neck, New York 11021

Re: K090336

Trade/Device Name: Powder-Free, Blue, Nitrile Examination Gloves Tested with

Chemotherapy Drugs

Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA, LZC Dated: June 25, 2009 Received: June 30, 2009

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 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.

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. 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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections $31-542 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/cdrh/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Anthony D.m
Susan Runner, D.D.S., M.A.

Acting 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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EXHIBIT #1

Indications for Use

510(k) Number (if known): K090336

Applicant: Sunmax Enterprise Shanghai Co Ltd

Device Name: Powder free Blue Nitrile Patient Examination Glove tested with chemotherapy drugs.

Indications for Use:

Chemotherapy drugs with their breakthrough times:

Dacarbazine	240 minutes
Cyclophosphamide(Cytoxan)	240 minutes
Doxorubicin Hydrochloride	240 minutes
Fluorouracil	240 minutes
Cisplatin	240 minutes
Etoposide (Toposar)	240 minutes
Paclitaxel (Taxol)	240 minutes
Thio-Tepa	23.3 minutes
Carmustine	18.7 minutes

Prescription Use AND/OR (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)

Shule A Murphy, MD
(Division Sign-Off)

Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K090336

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.