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

Device Description

Powder Free Nitrile Patient Examination Glove, Blue, White and Green Colored, Non-Sterile, Low Dermatitis Potential Labeling Claim, meets all of the requirements of ASTM D 6319-10.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided text:

Acceptance Criteria and Device Performance

Characteristic	Acceptance Criteria (Standards)	Reported Device Performance
Dimensions	ASTM D 6319-10	Meets
Physical Properties	ASTM D 6319-10	Meets
Freedom from pin-holes	ASTM D 5151-06ASTM D 6319-10	Meets
Powder Free Residue	ASTM D 6124-06ASTM D 6319-10	Meets
Biocompatibility (Dermal Sensitization)	Dermal Sensitization (as per ISO 10993-10:2010)	Not a contact skin sensitizer
Biocompatibility (Primary Skin Irritation)	Primary Skin Irritation Test (as per 16 CFR Part 1500.41)	Not a primary skin irritant
Low Dermatitis Potential	Modified Draize-95 Test	No clinical evidence presence of residual chemical additives that may induce Type IV allergy in human subjects. (This is the result of the study described below)

Study Details

Sample size used for the test set and the data provenance:
- Test Set Sample Size: 200 non-sensitized adult human subjects.
- Data Provenance: The document states the study subjects "reasonably reflect the general user population in the US," implying the study was conducted with a US-representative population, making it prospective in nature for the purpose of this assessment.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document does not specify the number of experts or their qualifications for establishing ground truth in the Modified Draize-95 Test. It only mentions that the study was "conducted" and "gave all negative results," indicating a clinical assessment.
Adjudication method for the test set:
- The document does not explicitly state an adjudication method (like 2+1 or 3+1). The "Modified Draize-95 Test" involves clinical observation and assessment.
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:
- No, an MRMC comparative effectiveness study was not done. This device is a patient examination glove, and the studies performed are related to its physical and biological properties in humans, not diagnostic reading by human experts with or without AI assistance.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, the performance of the device itself was evaluated in a standalone manner against established standards and through clinical testing. The Modified Draize-95 Test assessed the glove's potential to cause irritation or sensitization directly, without human "reading" of an output or an AI algorithm.
The type of ground truth used:
- For the "Low Dermatitis Potential" claim, the ground truth was clinical outcomes data from human subjects (i.e., observation of skin reactions like irritation or sensitization).
- For other characteristics (Dimensions, Physical Properties, Freedom from pin-holes, Powder Free Residue, Biocompatibility), the ground truth was based on adherence to quantitative and qualitative standards defined by ASTM and ISO.
The sample size for the training set:
- This is not applicable as the studies described are for verification and validation of a physical medical device (examination gloves), not for training an AI model.
How the ground truth for the training set was established:
- Not applicable, as there is no AI model or training set mentioned for this device.

Summary

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<120066

KOSSAN LATEX INDUSTRIES (M) SDN. BHD. (169832-K)

FDA 510(k), Premarket Notification: 510(k) Summary of Safety and Effectiveness Information

1.0 Submitter:

Kossan Latex Industries (M) Sdn Bhd Lot 6129, Jalan Haji Abdul Manan, Batu 5 1/4, Jalan Meru, Klang, 41050 Selangor, Malaysia

Telephone No.:	+603 3392 3088
Fax No.:	+603 3291 0584

2.0 Contact Person:

Contact:	Ms S F Cho
Telephone No.:	+603 3392 3088
Fax No.:	+603 3291 0584

3.0 09 November 2012 Preparation Date:

4.0 Name of Device:

Trade Name: Powder Free Nitrile Patient Examination Glove, Blue, White and Green Colored. Non-Sterile, Low Dermatitis Potential Claim. Common Name: . Powder-Free Nitrile Patient Examination Glove Classification Name: Patient Examination Glove (21 CFR Part 880.6250) Regulatory Class: Class I Product Code: 80 LZA

5.0 Identification of the Legally Marketed Device:

Powder Free Nitrile Patient Examination Glove, Blue, White and Green Colored, Non-Sterile, Low Dermatitis Potential Labeling Claim; Class I Patient Examination Gloves, Nitrile-80LZA, meets all of the requirements of ASTM D 6319-10 Standard Specification for Nitrile Examination Gloves for Medical Application.

Predicate Device: K102790, Powder Free Nitrile Patient Examination Glove, Blue, Non-Sterile (Low Dermatitis Potential and Chemotherapy Drugs Protection Labeling Claim).

NOV 1 6 2012

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6.0 Description of Device:

Powder Free Nitrile Patient Examination Glove, Blue, White and Green Colored, Non-Sterile, Low Dermatitis Potential Labeling Claim, meets all of the requirements of ASTM D 6319-10.

7.0 Intended Use of the Device:

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

Summary of the Technological Characteristics of the Device: 8.0

Powder Free Nitrile Patient Examination Glove, Blue, White and Green Colored, Non-Sterile, Low Dermatitis Potential Labeling Claim possesses the following technological characteristic (as compared to ASTM or equivalent standards):

Characteristic	Standards	Device Performance
Dimensions	ASTM D 6319-10	Meets
Physical Properties	ASTM D 6319-10	Meets
Freedom from pin-holes	ASTM D 5151-06ASTM D 6319-10	Meets
Powder Free Residue	ASTM D 6124-06ASTM D 6319-10	Meets
Biocompatibility	Dermal Sensitization(as per ISO 10993-10:2010)	Not a contact skin sensitizer
	Primary SkinIrritation Test(as per 16 CFR Part1500.41)	Not a primary skin irritant
Low DermatitisPotential	Modified Draize-95Test	No clinical evidence presence ofresidual chemical additives that mayinduce Type IV allergy in humansubjects.

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KOSSAN LATEX INDUSTRIES (M) SDN. BHD. (169832-K)

9.0 Substantial Equivalent Based on Assessment of Non-Clinical Performance Data

Testing was performed per ASTM D6319-10, ASTM D5151-06, ASTM D6124-06, ISO 10993-10:2010, and 16 CFR Part 1500.41. The gloves meet standard requirements referenced in Section 8.0 above. Biocompatibility test indicates the gloves are not a contact skin sensitizer and not a primary skin irritant.

10.0 Substantial Equivalent Based on Assessment of Clinical Performance Data

Powder Free Nitrile Patient Examination Glove, Blue, White and Green Colored, Non-Sterile, Low Dermatitis Potential Labeling Claim, were tested in accordance with Modified Draize-95 Test, per FDA's guidance document "Guidance for Industry and FDA Reviewers/Staff: Premarket Notification [510(k)] Submissions for Testing for Skin Sensitization to Chemicals in Natural Rubber Products, 1999".

The study was conducted in two stages. In the first stage, a population of 50 human subjects was tested to evaluate the product for the potential to cause irritation or sensitization. The second stage was initiated on a further number of subjects to a total of a minimum of 200 individuals after the first stage has shown that the test product does not indicate a potential for inducing dermal irritation and does not shown sensitization capability.

The study completed on 200 non-sensitized adult human subjects, who reasonably reflect the general user population in the US, gave all negative results. There was no clinical evidence of the presence of residual chemical additives at the level that may induce Type IV allergy in the un-sensitized general user population in the tested article.

11.0 Conclusion

It can be concluded that Powder Free Nitrile Patient Examination Glove, Blue, White and Green Colored, Non-Sterile, Low Dermatitis Potential Labeling Claim is safe and effective for use, and perform according to the glove performance standards referenced in Section 8.0 above, thereby meeting ASTM standards, FDA requirements, and the labeling claims for the product.

This device is substantially equivalent to currently marketed devices, per Substantial Equivalence Comparison Table below:-

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KOSSAN LATEX INDUSTRIES (M) SDN. BHD. (169832-K) K L 1

ubstantial Equivalence Comparison Tabl

Feature	K102790, Powder Free Nitrile Patient Examination Glove, Blue, Non-Sterile (Low Dermatitis Potential and Chemotherapy Drugs Protection Labeling Claim) Predicate Device	Powder Free Nitrile Patient Examination Glove, Blue, White and Green Colored, Non-Sterile (Low Dermatitis Potential Labeling Claim) Proposed Device
Intended Use	Intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner	Identical
Indications for Use	This glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.	A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
	This glove has been tested for use with specific chemotherapy drugs listed below.
	Chemotherapy Drug Breakthrough Detection Time in Minutes)
	Dacarbazine (DTIC) (10.0 mg/mL)
	Carmustine (BCNU) (3.3 mg/mL)
	Cyclophosphamide (Cytoxan) (20.0 mg/mL)
	Doxorubicin Hydrochloride (2.0 mg/mL)
	5-Fluorouracil (50.0 mg/mL)
	Etoposide (20.0 mg/mL)
	Paclitaxel (taxol) (6.0 mg/mL)
	Thio-Tepa (10.0 mg/mL)
Please note that Carmustine has extremely low permeation times of less than 30 minutes

Page 4 of 5 (Rev 2)

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KOSSAN LATEX INDUSTRIES (M) SDN. BHD. (169832-K)

K L 1 -

Material	Color	Single Use	Sterilization	Dimensions	Physical Properties	Freedom from Pinhole	Residue Powder	Biocompatibility Test	Human Draize Test	Chemotherapy Drugs Permeation Test	Labeling Claim
Nitrile	Blue	Yes	Not Applicable; Non-Sterile	Meets ASTM D6319	Meets ASTM D6319	Meets ASTM D5151 and ASTM D6319	Meets ASTM D6124 and ASTM D6319	Pass Dermal Sensitization TestPass Primary Skin Irritation Test	Pass	Meets ASTM D6978-05	Low Dermatitis and Chemotherapy Drugs ProtectionProposed device With Low Dermatitis Potential
Identical	Blue, White and Green	Identical	Identical	Identical	Identical	Identical	Identical	Identical	Identical	Not Applicable; Not Tested

. . . . . .

Page 5 of 5 (Rev 2)

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Image /page/5/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings outstretched.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

November 16, 2012

Kossan Latex Industries (M) Sdn Bhd Ms. Cho Sow Fong Manager Regulatory Affairs Lot 6129, Jalan Haji Abdul Manan, Batu 5 ¼ Jalan Meru, Klang, 41050 Selangor, Malaysia

Re: K120066

Trade/Device Name: Powder Free Nitrile Patient Examination Gloves, Blue, White and Green Colored, Non-Sterile (Low Dermatitis Potential Labeling Claim)

Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: November 1, 2012

Received: November 2, 2012

Dear Ms. Fong:

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 - Ms. Fong

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 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,

DN: c=US. o=U.S. Government, ou=HHS DA, ou=People, cn=Anthony U. Wa 342.19200300.100.1.1=1300092402 te: 2012.11.15 13:30:20 -05 00

Anthony D. Watson, B.S., M.S., M.B.A. Director

Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices

Office of Device Evaluation

Center for Devices and

Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known):

<120066

Device Name:

Powder Free Nitrile Patient Examination Gloves. Blue, White and Green Colored. Non-Sterile (Low Dermatitis Potential Labeling Claim)

Indications for Use:

A patient examination glove is a disposable device intended for medical purposes that is wom on the A patient exammation grove is a cispessor contamination between patient and examiner.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C) ×

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

Concurrence of CDRH, Office Of Device Evaluation (ODE)

Page 1 of

Mary S. Runne : 2012, 11, 16 13:13:32 -05'00

(Division Sign-Off) (Division of Anesthesiology, General Hospital Division Control, Dental Devices

510(k) Number: K120066

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.