A patient examination glove is disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
The tested chemotherapy drugs and their breakthrough detection times are as follows:

Chemotherapy Drug	Average BDT
Fluorouracil	>240 min.
Etoposide (Toposar)	>240 min.
Cyclophosphamide (Cytoxan)	>240 min.
Carmustine	2.03 min.
Thiotepa	25.23 min.
Paclitaxel (Taxol)	>240 min.
Doxorubicin Hydrochloride	>240 min.
Dacarbazine (DTIC)	>240 min.
Cisplatin	>240 min.
Please note that Carmustine and Thiotepa have extremely low permeation times of less than 30 minutes.

Device Description

Classified by FDA's General and Plastic Surgery Device panel as Class I, 21 CFR 880.6250, Polymer Patient Examination Gloves, 80 LZA, and meets all requirements of ASTM standard D 6319-00a (2005)e1.

AI/ML Overview

The provided text describes a 510(k) premarket notification for "Syntex Healthcare Products Co., Ltd Powder Free Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs (Blue)". This is a medical device approval application, not a study of an AI/ML device. Therefore, the specific questions related to AI/ML device performance, such as sample sizes for test sets, expert ground truth, MRMC studies, and standalone algorithm performance, are not applicable.

However, I can extract the acceptance criteria and performance data for this device as it relates to the non-clinical tests conducted.

1. A table of acceptance criteria and the reported device performance

The acceptance criteria are generally established by recognized standards like ASTM D 6319-00a (2005)e1, ASTM D6124-06, ISO 10993 Part 10, and 16CFR 1500.41/1500.3. The "Performance Results" column indicates if the device meets these standards.

Characteristics	Applicable Recognized Standards	Reported Device Performance
Dimensions	ASTM D 6319-00a (2005)e1	Meets
Physical Properties	ASTM D 6319-00a (2005)e1	Meets
Freedom from holes	(FDA Pinhole requirements)	Meets
Residual Powder Test	ASTM D 6319-00a (2005)e1, ASTM D6124-06	Meets
Primary Skin Irritation and Skin Sensitization	ISO 10993 Part 10, 16CFR 1500.41, 16CFR 1500.3	Meets
Resistance to Permeation (Chemotherapy Drugs)	ASTM D6978-05	See specific breakthrough detection times below

Breakthrough Detection Times (BDT) for Chemotherapy Drugs (Resistance to Permeation):

Chemotherapy Drug	Average BDT
Fluorouracil	>240 min.
Etoposide (Toposar)	>240 min.
Cyclophosphamide (Cytoxan)	>240 min.
Carmustine	2.03 min.
Thiotepa	25.23 min.
Paclitaxel (Taxol)	>240 min.
Doxorubicin Hydrochloride	>240 min.
Dacarbazine (DTIC)	>240 min.
Cisplatin	>240 min.

Important Note: The document explicitly states: "Please note that Carmustine and Thiotepa have extremely low permeation times of less than 30 minutes." This implies that while the device was tested against these drugs, their low BDTs are a critical factor for users to consider, and the labeling states "Do not use with Carmustine and Thiotepa."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not explicitly state the sample sizes for each non-clinical test (e.g., how many gloves were tested for dimensions, physical properties, or permeation). It mentions the tests were performed by Syntex Healthcare Products Co., Ltd in China (the submitter's location), so the data likely originates from China. The tests are non-clinical and would be considered prospective for the purpose of the 510(k) submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
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
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
8. The sample size for the training set
9. How the ground truth for the training set was established

These questions are designed for AI/ML device evaluations. The presented document describes a traditional medical device (examination gloves) and its non-clinical testing. Therefore, these questions are not applicable to this submission. The "ground truth" for this device is determined by physical and chemical testing against established standards (e.g., ASTM standards for glove properties and permeation resistance). No AI/ML components are mentioned or evaluated in this 510(k) summary.

Summary

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OCT 4 2010

510(K) SUMMARY

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

The assigned 510(K) number is: ___ K | 020 96

1. Submitter's Identification:

Mr. Xiaolin Shen Syntex Healthcare Products Co., Ltd No. 1 Fanjiazhuang Industrial, Zone, Xinji City, Hebei Province, China 052360 Tel: 86-311-83980319

Date Summary Prepared: June 7, 2010

2. Name of the Device:

Syntex Healthcare Products Co., Ltd Powder Free Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs (Blue)

3. Predicate Device Information:

Medline Industries Incorporated Mediguard Powder Free Nitrile Examination Glove (Blue)- Tested for use with Chemotherapy (K093726)

4. Device Description:

Classified by FDA's General and Plastic Surgery Device panel as Class I, 21 CFR 880.6250, Polymer Patient Examination Gloves, 80 LZA, and meets all requirements of ASTM standard D 6319-00a (2005)e1.

5. Intended Use:

A patient examination glove is disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

The tested chemotherapy drugs and their breakthrough detection times are as follows:

Chemotherapy Drug	Average BDT
Fluorouracil	>240 min.
Etoposide (Toposar)	>240 min.
Cyclophosphamide (Cytoxan)	>240 min.
Carmustine	2.03 min.
Thiotepa	25.23 min.

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K102096

EXHIBIT #1 Page 2 of 3

Paclitaxel (Taxol)	>240 min.
Doxorubicin Hydrochloride	>240 min.
Dacarbazine (DTIC)	>240 min.
Cisplatin	>240 min.

Please note that Carmustine and Thiotepa have extremely low permeation times of less than 30 minutes.

6. Comparison to Predicate Devices:

Syntex Healthcare Products Co., Ltd's Powder Free Nitrile Examination Gloves, Blue, Tested for Use with Chemotherapy Drugs is substantially equivalent in safety and effectiveness to the Medline Industries, Incorporated's Mediguard Powder Free Nitrile Examination Glove (Blue)- Tested for use with Chemotherapy.

7. Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as Follows:

Characteristics	ApplicableRecognized Standards	Performance Results
Dimensions	ASTM D 6319-00a(2005)e1	Meets
Physical Properties	ASTM D 6319-00a(2005)e1	Meets
Freedom from holes		Meets
Residual Powder Test	ASTM D 6319-00a(2005)e1ASTM D6124-06	Meets
Primary Skin Irritationand Skin Sensitization	ISO 10993 Part 1016CFR 1500.4116CFR 1500.3	Meets
Resistance to Permeation	ASTM D6978-05	See Data in Section 5

8. Labeling:

Powder Free Nitrile Examination Gloves, Blue, Tested for Use with Chemotherapy Drugs with a chemotherapy claim, tested per ASTM D6978-05, and provide protection against: Fluorouracil, Etoposide (Toposar), Cyclophosphamide (Cytoxan), Paclitaxel (Taxol), Doxorubicin Hydrochloride, Dacarbazine (DTIC), Cisplatin. Do not use with Carmustine and Thiotepa. The tested chemotherapy drugs' breakthrough detection times, refer to item 5 in this summary for details.

We do not claim our gloves as hypoallergenic on our labels.

9. Discussion of Clinical Tests Performed:

Not Applicable - There is no hypoallergenic Claim.

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K102096

EXHIBIT #1 Page 3 of 3

10. Conclusions:

Syntex Healthcare Products Co., Ltd's Powder Free Nitrile Examination Gloves, Blue, Tested for Use with Chemotherapy Drugs conform fully to ASTM D 6319-00a (2005)e1 standard as well as applicable 21 CFR references, and meets pinhole FDA requirements, biocompatibility requirements and labeling claims as shown by data in Section 7. There are no safety/efficacy issues or new claims from the "substantial equivalence" products cited.

Drawn from the complete list of non-clinical tests, the device is as safe and effective as the legally marketed predicate device K093726 Mediguard Powder Free Nitrile Examination Glove (Blue) Tested for Use with Chemotherapy Drugs.

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

Syntex Healthcare Products Company, Limited C/O Ms. Kathy Liu Surprotect Incorporated 3973 Schaefer Avenue Chino, California 91710

OCT 4 2010

Re: K102096

Trade/Device Name: Powder Free Nitrile Examination Glove, Tested for Use With Chemotherapy Drugs (Blue) Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Přoduct Code: LZA, LZC Dated: September 7, 2010 Received: September 8, 2010

Dear Ms. Liu:

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 from 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 Eederal Register.

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Page 2- Ms. Liu

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 genies. 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 S31-542 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 pntifics: 'on''' (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.htm1 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/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Wh for

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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K102096

Attachment A

INDICATION FOR USE

K102096 510 (k) NUMBER (IF KNOW): APPLICANT: DEVICE NAME:

Syntex Healthcare Products Co., Ltd Powder Free Nitrile Examination Glove, Tested for Use with Chemotherapy Drugs (Blue)

INDICATIONS FOR USE:

A patient examination glove is disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

The tested chemotherapy drugs and their breakthrough detection times are as follows:

Chemotherapy Drug	Average BDT
Fluorouracil	>240 min.
Etoposide (Toposar)	>240 min.
Cyclophosphamide (Cytoxan)	>240 min.
Carmustine	2.03 min.
Thiotepa	25.23 min.
Paclitaxel (Taxol)	>240 min.
Doxorubicin Hydrochloride	>240 min.
Dacarbazine (DTIC)	>240 min.
Cisplatin	>240 min.

Please note that Carmustine and Thiotepa have extremely low permeation times of less than 30 minutes.

Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter-Use _ (21CFR 801 Subpart C)

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

AND/ OR

Eslizlth F. (Laurete-Wilbs

Concurrent of CDRH, Office of Payiston Sigmeation (C (ORISSON Sigmation (ODE)
Division of Anesthesiology, General Hospital
Division of Anesthesion Devices

Division of Anesthesia, Dental Devices
Infection Control, Dental Devices
510(k) Number: K102096

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.