K Number

Device Name

POWDER FREE NITRILE PATIENT EXAMINATION GLOVE, BLUE AND WHITE COLORED, NON-STERILE

Manufacturer

WEAR SAFE (MALAYSIA) SDN BHD - FACILITY II

Date Cleared

2013-02-19

(98 days)

Product Code

LZA

Regulation Number

880.6250

Intended Use

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 Colored, and White (Non Colored), Non-Sterile meets all of the requirements of ASTM D 6319-10. The gloves are ambidextrous single-use disposable devices that come in five sizes (XS, S, M, L, XL) in blue or white color.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K093500, K111772

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device is a standard patient examination glove, and the description focuses on material properties and compliance with ASTM standards, with no mention of AI or ML.

Therapeutic

No.
The device, a patient examination glove, is intended to prevent contamination, not to treat or cure any medical condition.

Diagnostic

Explanation: The device is a patient examination glove, intended to prevent contamination between patient and examiner. Its function is protective, not diagnostic.

SaMD (Software as a Medical Device)

The device description clearly states it is a physical patient examination glove made of nitrile, which is a hardware component.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
Device Function: The described device is a patient examination glove. Its purpose is to create a physical barrier between the examiner and the patient to prevent contamination. It does not involve the analysis of biological specimens.
Intended Use: The intended use clearly states it's for preventing contamination between patient and examiner, not for diagnosing or monitoring a medical condition through the analysis of samples.

The information provided about the device's characteristics, performance testing (against standards like ASTM D 6319-10), and predicate devices all relate to its function as a protective barrier, not as a diagnostic tool.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

Product codes (comma separated list FDA assigned to the subject device)

LZA

Device Description

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

hand

Indicated Patient Age Range

Not Found

Intended User / Care Setting

examiner

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

The device was tested against the following standards:

Dimensions: ASTM D 6319-10 (Meets)
Physical Properties: ASTM D 6319-10 (Meets)
Freedom from pin-holes: ASTM D 5151-06 (Meets), ASTM D 6319-10 (Meets)
Powder Free Residue: ASTM D 6124-06 (Meets), ASTM D 6319-10 (Meets)
Biocompatibility: Dermal Sensitization (as per ISO 10993-10:2010), not a contact skin sensitizer. Primary Skin Irritation Test (as per 16 CFR Part 1500), not a primary skin irritant.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K093500, K111772

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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.

Summary

WSM WEAR SAFE (MALAYSIA) SDN BHD

(Company No. 204396-X)

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

1.0 Submitter:

K423469

Wear Safe (Malaysia) Sdn Bhd - Facility II LOT 63616, PT 54924, NO 3, Jalan Korporat 7C/KU9, Taman Perindustrian Meru, Mukim Kapar, 42200 Klang, Selangor, Malaysia

Telephone No.:	+603-3393 6088
Fax No.:	+603-3393 3688

2.0 Contact Person:

Contact:	Mr Alex Yoong
Telephone No.:	+603-3393 6088
Fax No .:	+603-3393 3688

3.0 Preparation Date: 15 February 2013

4.0 -Name of Device:

Trade Name: Powder Free Nitrile Patient Examination Glove, Blue Colored, and White (Non-Colored). Non-Sterile, Polymer Coated Powder Free Nitrile Patient Examination Glove, Blue Colored, and White (Non-Colored). Non-Sterile, Without Polymer (Chlorinated) Common Name: Powder-Free Nitrile Patient Examination Glove Classification Name: Patient Examination Glove (21 CFR Part 880.6250, Product Code LZA)

5.0 Identification of the Legally Marketed Device:

Powder Free Nitrile Patient Examination Glove, Blue Colored, and White (Non Colored), Non-Sterile; 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 1: K093500, Powder Free Nitrile Examination Glove, White (Non-Colored) and Blue (Colored), Non-Sterile (Chemotherapy Drug Protection Labeling Claim).

Predicate Device 2: K111772, Powder Free Nitrile Patient Examination Glove, Blue Colored and White (Non-Colored), Non-Sterile.

WSM WEAR SAFE (MALAYSIA) SDN BHD

(Company No. 204396-X)

There are no different technological characteristics compared to the Predicate Devices. They are all Powder Free Non-Sterile Nitrile Examination Gloves, one predicate polymer coating (K111772), and the other on-line chlorination (K093500).

6.0 Description of Device:

Intended Use of the Device: 7.0

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.

8.0 Summary of the Technological Characteristics of the Device:

Powder Free Nitrile Patient Examination Glove, Blue Colored, and White (Non Colored). Non-Sterile 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 5151-06	Meets
	ASTM D 6319-10	Meets
Powder Free Residue	ASTM D 6124-06	Meets
	ASTM D 6319-10	Meets
Biocompatibility	Dermal Sensitization
(as per ISO 10993-
10:2010)	Not a contact skin sensitizer
	Primary Skin
Irritation Test
(as per 16 CFR Part

| Not a primary skin irritant |

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

The performance test data that support a determination of substantial equivalence are described above.

WSM WEAR SAFE (MALAYSIA) SDN BHD

(Company No. 204396-X)

10.0 Substantial Equivalent Based on Assessment of Clinical Performance Data

Clinical data is not needed for gloves or for most devices cleared by the 510(k) process.

11.0 Conclusion

Powder Free Nitrile Patient Examination Glove, Blue Colored, and White (Non Colored), Non-Sterile performs according to the glove performance standards referenced in Section 8.0 above. This device is substantially equivalent to current marketed devices per Section 12.0.

12.0 Substantial Equivalence Comparison and Analysis

The gloves are identical to Predicate Device cleared under 510(k) K093500 with Proposed Device not tested for use with chemotherapy drugs. The difference with Chemotherapy Protection Labeling Claim in Predicate Device, does not affect the safety and effectiveness of the Proposed Device that is not tested for Chemotherapy Drugs used.

The gloves are also identical to Predicate Device cleared under 510 (k) K111772, both devices are not tested for use with chemotherapy drugs. Predicate Device is with Polymer Coated Labeling Claim, while Proposed Device is with Polymer Coated optional labeling claim.

There is difference in Blue colorant used in Proposed Device, compared with Predicate Devices. The difference Does Not affect the safety and effectiveness of the Proposed Device, as the Proposed Device Pass biocompatibility test, similar with Predicate Devices.

There is no difference between the Proposed Device and the Predicates with respect to indications for use and technological characteristics.

As such, this device is substantially equivalent to currently marketed devices. The Substantial Equivalence Comparison is summarized per Table below:-

WSM WEAR SAFE (MALAYSIA) SDN BHD

Substantial Equivalence Comparison Table

Characteristics	Predicate Device 1	Proposed Device	Predicate Device 2	Proposed Device
	K093500, Powder Free
Nitrile Examination Glove,
White (Non-Colored) and
Blue (Colored), Non-Sterile
(Chemotherapy Drug
Protection Labeling Claim)
of Wear Safe (Malaysia)
Sdn Bhd	Powder Free Nitrile
Patient Examination
Glove, Blue Colored,
and White (Non
Colored), Non-Sterile	K111772, Powder Free
Nitrile Patient
Examination Glove, Blue
Colored and White (Non-
Colored), Non-Sterile of
Kossan Latex Industries
(M) Sdn Bhd.	Powder Free Nitrile Patient
Examination Glove, Blue
Colored, and White (Non
Colored), Non-Sterile
Product Code	80 LZC	80 LZA	80 LZA	Identical
Intended Use	Intended for medical purposes
that is worn on the examiner's
hand to prevent contamination
between patient and examiner.	Identical	Intended for medical
purposes that is worn on the
examiner's hand to prevent
contamination between
patient and examiner.	Identical
Design	Powder Free, Non Sterile,
Ambidextrous, Beaded Cuff	Identical	Powder Free, Non Sterile,
Ambidextrous, Beaded Cuff	Identical
Indications for Use	A powder free nitrile
examination glove is a
disposable device made of
synthetic material intended to
be worn on the hand for
medical purposes to provide
barrier against potentially
infectious materials and other
contaminants.
In addition, this product is
tested for use with
chemotherapy drugs	Identical	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.	Identical
Characteristics	Predicate Device 1
K093500, Powder Free Nitrile Examination Glove, White (Non-Colored) and Blue (Colored), Non-Sterile (Chemotherapy Drug Protection Labeling Claim) of Wear Safe (Malaysia) Sdn Bhd	Predicate Device 2
K111772, Powder Free Nitrile Patient Examination Glove, Blue Colored and White (Non-Colored), Non-Sterile of Kossan Latex Industries (M) Sdn Bhd.	Proposed Device
Powder Free Nitrile Patient Examination Glove, Blue Colored, and White (Non Colored), Non-Sterile
Construction	Ambidextrous, Chlorinated, Powder Free Nitrile.	Ambidextrous, Polymer Coated, Powder Free Nitrile.	Ambidextrous, Polymer Coated or Chlorinated, Powder Free.
Color Description	Blue and White	Blue and White	Identical
Materials	Nitrile	Nitrile	Identical
Performance
I. Sterility	Non-Sterile	Non-Sterile	Identical
II. Freedom from holes	Meets ASTM D6319	Meets ASTM D6319	Identical
III. Dimension	Meets ASTM D6319	Meets ASTM D6319	Identical
IV. Physical Properties	Meets ASTM D6319	Meets ASTM D6319	Identical
V. Powder Free Residue	Meets ASTM D6319	Meets ASTM D6319	Identical
Single Use	Yes	Yes	Identical
Biocompatibility Test	Passes
i. Primary Skin Irritation Test
ii. Dermal Sensitization Test	Passes
i. Primary Skin Irritation Test
ii. Dermal Sensitization Test	Identical
Characteristics	Predicate Device 1
K093500, Powder Free Nitrile
Examination Glove, White (Non-Colored) and
Blue (Colored), Non-Sterile (Chemotherapy
Drug Protection Labeling Claim)
of Wear Safe (Malaysia) Sdn Bhd	Proposed Device
Powder Free Nitrile
Patient Examination
Glove, Blue Colored, and
White (Non Colored), Non-Sterile	Predicate Device 2
K111772, Powder Free Nitrile
Patient Examination Glove, Blue
Colored and White (Non-Colored), Non-Sterile of
Kossan Latex Industries
(M) Sdn Bhd.	Proposed Device
Powder Free Nitrile Patient
Examination Glove, Blue
Colored, and White (Non
Colored), Non-Sterile
Packaging	Packed in Dispenser Boxes	Identical	Packed in Dispenser Boxes	Identical
Labeling Claim	Tested For Use with
Chemotherapy Drugs
Labeling Claim	Not Tested For Use with
Chemotherapy Drugs	i. NO Chemotherapy
Drugs Labeling Claim
ii. Polymer Coated
Labeling Claim	Optional Polymer Coated
Labeling Claim

WSM WEAR SAFE (MALAYSIA) SDN BHD
Comment

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WSM WEAR SAFE (MALAYSIA) SDN BHD
(00000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000

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Image /page/6/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of stylized lines.

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

February 19, 2013

Mr. Alex Yoong Quality Assurance Manager . Wear Safe (Malaysia) Sdn Bhd - Facility II Lot 63616. PT 54924, NO 3, Jalan Korporat 7C/KU9 Taman Perindustrian Meru Mukim Kapar, Klang Selangor, Malaysia 42200

Re: K123469

Trade/Device Name: Powder Free Nitrile Patient Examination Gloves, Blue Colored and White (Non-Colored), Non-Sterile, Polymer Coated Powder Free Nitrile Patient Examination Gloves, Blue Colored and White (Non-Colored), Non-Sterile, Without Polymer (Chlorinated)

Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: January 2, 2013 Received: January 10, 2013

Dear Mr. Yoong:

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. 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

Page 2 - Mr. Yoong

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 devicerelated 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 n you aco.il/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,

hori
Theti
Fawshukio.

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

Indications for Use

K123469

510(k) Number (if known):

Device Name:

Powder Free Nitrile Patient Examination Gloves, Blue Colored and White (Non-Colored), Non-Sterile, Polymer Coated Powder Free Nitrile Patient Examination Gloves. Blue Colored and White (Non-Colored), Non-Sterile, Without Polymer (Chlorinated)

Indications for Use:

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.

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)

Elizabeth-F.Claverie
2013.02.15 22:09:47 -05'00'

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

510(k) Number: K123469

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