A disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. This device is single use only. Tested for use with chemotherapy drugs. Tested chemotherapy drugs are as follows (Fluorouracil, Etoposide, Cyclophosphamide, Carmustine, Thio-Tepa, Paclitaxel, Doxorubicin Hydrochloride, Dacarbazine, Cisplatin)

Device Description

Blue and Red with Pearlescent® Pigment. Powder Free Nitrile Examination Gloves with Aloe Vera, Tested for use with Chemotherapy Drugs meets all the requirements of ASTM D 6978-05, ASTM D6319-00a(2005) and FDA 21 CFT 880.6250.

AI/ML Overview

The provided text describes the acceptance criteria and performance for "Blue and Red with Pearlescent® Pigment, Powder Free Nitrile Examination Gloves with Aloe Vera, Tested for use with Chemotherapy Drugs" (K101436). It focuses on the physical properties and, most significantly, the resistance to permeation by chemotherapy drugs.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Characteristic	Acceptance Criteria (Standard)	Device Performance (Red Gloves)	Device Performance (Blue Gloves)
Dimensions	ASTM D 6319-00a05	Meets	Meets (Implied to be same as Red, as general statement applies to both)
Physical Properties	ASTM D 6319-00a05	Meets	Meets (Implied to be same as Red, as general statement applies to both)
Freedom from pinholes	ASTM D 5151-06	Meets (AQL 2.5)	Meets (AQL 2.5) (Implied to be same as Red, as general statement applies to both)
Powder Residual	ASTM D 6124-06	Meets (<2mg/glove)	Meets (<2mg/glove) (Implied to be same as Red, as general statement applies to both)
Biocompatibility (Primary Skin Irritation in Rabbits)	Passes (Not a primary skin irritant)	Passes (Not a primary skin irritant)	Passes (Not a primary skin irritant) (Implied to be same as Red, as general statement applies to both)
Biocompatibility (Dermal Sensitization)	Passes (Not a primary skin irritant)	Passes (Not a primary skin irritant)	Passes (Not a primary skin irritant) (Implied to be same as Red, as general statement applies to both)
Resistance to permeation by Chemotherapy Drugs	ASTM D6978-05	Meets (See detailed breakthrough times below)	Meets (See detailed breakthrough times below)
Cyclophosphamide	Breakthrough Detection Time per ASTM D6978-05	>240 min	>240 min
Doxorubicin HCl (Adriamycin)	Breakthrough Detection Time per ASTM D6978-05	>240 min	>240 min
Carmustine	Breakthrough Detection Time per ASTM D6978-05	0.68 min	2.10 min
Etoposide	Breakthrough Detection Time per ASTM D6978-05	>240 min	>240 min
Fluorouracil (Adrucil)	Breakthrough Detection Time per ASTM D6978-05	>240 min	>240 min
Paclitaxel (Taxol)	Breakthrough Detection Time per ASTM D6978-05	>240 min	>240 min
ThioTEPA	Breakthrough Detection Time per ASTM D6978-05	34.21 min	27.17 min
Dacarbazine	Breakthrough Detection Time per ASTM D6978-05	>240 min	>240 min
Cisplatin	Breakthrough Detection Time per ASTM D6978-05	>240 min	>240 min

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

The document does not explicitly state the sample size used for the test set for each specific characteristic. It refers to compliance with ASTM standards. For instance, for Resistance to permeation by Chemotherapy Drugs, it refers to ASTM D6978-05. This standard would specify the number of samples required for testing. For Freedom from pinholes, it mentions "AQL 2.5," which is an Acceptance Quality Limit and implies a specific sampling plan, but the exact number of gloves tested isn't stated.

Data Provenance: The data appears to be prospective, generated specifically for this 510(k) submission to demonstrate compliance with the referenced ASTM standards. The country of origin of the data is not specified beyond being submitted by Shen Wei (USA) Inc.

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

This type of medical device (nitrile examination gloves) does not typically involve human experts to establish "ground truth" in the way a diagnostic imaging AI algorithm would. The "ground truth" for the performance characteristics (e.g., tensile strength, pinholes, chemical permeation) is established through standardized laboratory testing procedures as defined by the relevant ASTM (American Society for Testing and Materials) standards. The results are objective measurements rather than subjective expert interpretations. Therefore, no information on "number of experts" or their "qualifications" for ground truth establishment is provided or relevant in this context.

4. Adjudication Method for the Test Set

Not applicable. As noted above, the ground truth is established by objective measurements based on standardized testing, not by expert consensus requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for diagnostic devices where human readers (e.g., radiologists) interpret images or data, and AI assistance can impact their performance. Nitrile examination gloves are a physical barrier device, and their performance is evaluated through material science and chemical permeation tests, not through human interpretation tasks.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, the performance reported for the gloves for all characteristics (dimensions, physical properties, pinholes, powder residual, biocompatibility, and chemotherapy drug permeation) represents the standalone performance of the device without human-in-the-loop. The tests are designed to measure the inherent properties of the glove material.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The ground truth used for the device's performance claims is based on objective measurements derived from standardized laboratory tests defined by ASTM (American Society for Testing and Materials) standards. This is often referred to as analytical performance or technical performance data.

For physical properties, it's measurements against ASTM D 6319-00a05.
For freedom from pinholes, it's a test against ASTM D 5151-06.
For powder residual, it's a test against ASTM D 6124-06.
For biocompatibility, it's a test for primary skin irritation and dermal sensitization.
For resistance to chemotherapy drugs, it's permeation testing according to ASTM D6978-05.

8. The Sample Size for the Training Set

Not applicable. This device is a physical product (nitrile gloves), not an algorithm or an AI system that requires a "training set." The concept of a training set is relevant for machine learning models, which are not involved in the development or testing of these gloves.

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

Not applicable, as there is no training set for this type of device.

Summary

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R101436

510(k) SUMMARY

1.0 Submitter

NOV 1 7 2010

Name Street Address Phone No. Fax No.

Shen Wei (USA) Inc. 33278 Central Ave., Suite 102 Union City, CA. 94587 (510)429-8692 (510)487-5347

x No.

(St

Date of Summary Prepared: 08/12/10 Prepared by: Albert Li

2.0 Name of the device:

Glove Proprietary or Trade Name: Blue and Red with Pearlescent® Pigment, Powder Free Nitrile Examination Gloves with Aloe Vera, Tested for use with Chemotherapy Drugs

Common Name: Exam gloves

Classification Name: Patient examination glove, Specialty Chemotherapy (per 21 CFR 880.6250 product code LZC)

Classification Information: Class I Nitrile patient examination glove 80LZC, powder-free and meeting all the requirements of ASTM D 6319-00a-05 and is tested with chemotherapy drugs according to ASTM D 6978-05.

Identification of the Legally Marketed Device: 3.0 :

Blue and Red with Pearlescent® Pigment. Powder Free Nitrile Examination Gloves with Aloe Vera Regulatory Class I Nitrile patient examination Product code: 80LZA 510(k): K092411

4.0 Description of the Device:

રું... Intended Use of Device:

Product: Red with Pearlescent® Pigment, Powder Free Nitrile Examination Gloves with Aloe Vera, Tested for use with Chemotherapy Drugs

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KIDI436

Thio-Tepa, Paclitaxel, Doxorubicin Hydrochloride, Dacarbazine, Cisplatin)

Chemotherapy Drug Permeation (Breakthrough Detection Time) in Min
The following chemicals have been tested with these gloves.
Cyclophosphamide	>240
Doxorubicin HCl (Adriamycin)	>240
*Carmustine	0.68
Etoposide	>240
Fluorouracil (Adrucil)	>240
Paclitaxel (Taxol)	>240
*ThioTEPA	34.21
Dacarbazine	>240
Cisplatin	>240

Please note that the following drug have extremely low permeation times of less than 30 minutes, Carmustine has an average breakthrough time of 0.68 minutes.

Please note that the following drug have extremely low permeation times of less than 60 minutes, Thiotepa has an average breakthrough time of 34.21 minutes.

5.1 Intended Use of Device:

Product: Blue with Pearlescent® Pigment, Powder Free Nitrile Examination Gloves with Aloe Vera, Tested for use with Chemotherapy Drugs

Chemotherapy Drug Permeation (Breakthrough Detection Time) in Minutes.
The following chemicals have been tested with these gloves.
Cyclophosphamide	>240
Doxorubicin HCl (Adriamycin)	>240
*Carmustine	2.10
Etoposide	>240
Fluorouracil (Adrucil)	>240
Paclitaxel (Taxol)	>240
*ThioTEPA	27.17
Dacarbazine	>240
Cisplatin	>240

Please note that the following drugs have extremely low permeation times of fess than 30 minutes, Carmustine has an average breakthrough time of 2.10 minutes. Thiotepa has an average breakthrough time of 27.17 minutes.

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Summary of Technological Characteristics for Modified Device: 6.0

Blue and Red with Pearlescent® Pigment, Powder Free Nitrile Examination Gloves with Aloe -Vera, Tested-for-use-with-Chemotherapy-Drugs are summarized with.the following technological characteristics compared to ASTM or equivalent standards.

Characteristics	Standards	Device Performance
Dimensions	ASTM D 6319-00a05	Meets
Physical Properties	ASTM D 6319-00a05	Meets
Freedom from pinholes	ASTM D 5151-06	Meets (AQL 2.5)
Powder Residual	ASTM D 6124-06	Meets (<2mg/glove)
Biocompatibility	Primary Skin Irritation in Rabbits	Passes(Not a primary skin irritant)
Biocompatibility	Dermal Sensitization	Passes(Not a primary skin irritant)
Resistance to permeationby Chemotherapy Drugs	ASTM D6978-05	Meets

All other characteristics including appearance, thickness, material, physical properties are equivalent to the predicate device. This 510(k) submission is to seek approval for the device to be marketed with the ASTM D6978-05 claim on resistance to permeation by chemotherapy drugs.

Characteristic and	Shen Wei USA	Shen Wei USA	Substantial
parameters	INC. (New Device)	INC. K032024	Equivalence (SE)
Product Code	LZA	LZA	SE
Intended Use	A disposable deviceintended for medicalpurpose that is wornon the examiner'shand to preventcontaminationbetween patient andexaminer. Thisdevice issingle use only.Tested for use withchemotherapydrugs. Testedchemotherapydrugs are as follows(Fluorouracil,Etoposide,Cyclophosphamide,Carmustine, Thio-	A disposable deviceintended for medicalpurpose that is wornon the examiner'shand to preventcontaminationbetween patient andexaminer. Thisdevice issingle use only.(Tested for use withchemotherapydrugs).	SE

Substantial Equivalence Discussion: 7.0

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KID1436

	Tepa, Paclitaxel,DoxorubicinHydrochloride,Dacarbazine,Cisplatin)
Width (size	95mm	95mm	SE
Medium)
Overall Length	240mm	240mm	SE
Palm Thickness	0.19mm	0.19mm
Finger Thickness	0.21mm	0.21mm
Tensile strength pre-	19 MPa	19 MPa
aging min
Tensile strength	20 MPa	20 MPa	SE
after aging min
Ultimate elongation	550%	550%
pre-aging min.
Ultimate elongation	રરુજરાજ	550%
after aging min
Meets	yes	YES
Biocompatibility
Skin irritation test	Passes	Passes	SE
Dermal sensitization	Passes	Passes

8.0 Conclusion:

Blue and Red with Pearlescent® Pigment, Powder Free Nitrile Examination Gloves with Aloe Vera, Tested for use with Chemotherapy Drugs will perform according to the glove performance standards reference in section 7 above and meet ASTM standards, and FDA requirements for water leak test on pinhole AQL. Consequently, this device is substantially equivalent to currently marketed devices.

Albert Li, Project Manager

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Image /page/4/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" in all caps. The text is in a bold, sans-serif font. The text is centered horizontally in the image. The background of the image is white.

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

Mr. Albert Li Project Manager Shen Wei (USA), Incorporated 33278 Central Avenue, Suite 102 Union City, California 94587

NOV 17 2010

Re: K101436

Trade/Device Name: Red & Blue with Pearlescent® Pigment, Powder Free Nitrile Examination Gloves with Aloe Vera. Tested for use with Chemotherapy Labeling Claims

Regulation Number: 21 CFR 880.6250

Regulation Name: Patient Examination Glove Regulatory Class: 1 Product Code: LZA / LZC Dated: October 18, 2010 Received: October 28, 2010

Dear Mr. Li:

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. Li

Please be advised that FDA's issuance of a substantial equivalence determination does notmean 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 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,

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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K101436

1-A. Indiction for Use

INDICATION FOR USE

Shen Wei (USA) Inc. Applicant:

NOV 1 7 2010

Device Name: Blue with Pearlescent® Pigment, Powder Free Nitrile Examination Gloves with Aloe Vera. Tested for use with Chemotherapy Drugs

Indication For Use:

Chemotherapy Drug Permeation (Breakthrough Detection Time) in Minutes.
The following chemicals have been tested with these gloves.
Cyclophosphamide	>240
*Carmustine	2.10
Doxorubicin HCl (Adriamycin)	>240
Etoposide	>240
Fluorouracil (Adrucil)	>240
Paclitaxel (Taxol)	>240
*ThioTEPA	27.17
Dacarbazine	>240
Cisplatin	>240

Please note that the following drugs have extremely low permeation times of less than 30 minutes, Carmustine has an average breakthrough time of 2.10 minutes. Thiotepa has an average breakthrough time of 27.17 minutes.

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

Concurrence of CDRH Office of Device Evaluation (ODE)

Elaine S. Manhall
OFF) for SFC

Infection Control, Dent

Prescription Use
FR 001-100

Per 21CFR 801.109

510(k) Number: K

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1-B. Indiction for Use_

INDICATION FOR USE

NOV 1 / 2010

Applicant: Shen Wei (USA) Inc.

Device Name: Red with Pearlescent® Pigment, Powder Free Nitrile Examination Gloves with Aloe Vera, Tested for use with Chemotherapy Drugs

Indication For Use:

Chemotherapy Drug Permeation (Breakthrough Detection Time) in Minutes.
The following chemicals have been tested with these gloves.
Cyclophosphamide	>240
Doxorubicin HCl (Adriamycin)	>240
*Carmustine	0.68
Etoposide	>240
Fluorouracil (Adrucil)	>240
Paclitaxel (Taxol)	>240
*ThioTEPA	34.21
Dacarbazine	>240
Cisplatin	>240

Please note that the following drug have extremely low permeation times of less than 30 minutes. Carmustine has an average breakthrough time of 0.68 minutes.

Please note that the following drug have extremely low permeation times of less than 60 minutes, Thiotepa has an average breakthrough time of 34.21 minutes.

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

Concurrence of CDRH Office of Device Evaluation (ODE)

Elaine S. Mayhall

Prescription Use Per 21CFR 801.109

510(k) Number:

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.