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

K123469 · Wear Safe (Malaysia) Sdn Bhd - Facility II · LZA · Feb 19, 2013 · General Hospital

Device Facts

• Record ID: K123469
• Device Name: POWDER FREE NITRILE PATIENT EXAMINATION GLOVE, BLUE AND WHITE COLORED, NON-STERILE
• Applicant: Wear Safe (Malaysia) Sdn Bhd - Facility II
• Product Code: LZA · General Hospital
• Decision Date: Feb 19, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

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 Story

Disposable, ambidextrous, non-sterile nitrile examination gloves; available in blue or white; five sizes (XS-XL). Manufactured via polymer coating or chlorination. Used by healthcare professionals in clinical settings to provide a barrier against infectious materials and contaminants. Device is single-use; worn on hands during patient examinations. Benefits include reduction of cross-contamination risk between patient and examiner. No electronic or software components.

Clinical Evidence

Bench testing only. No clinical data provided. Performance verified against ASTM D6319-10 (dimensions, physical properties, powder residue), ASTM D5151-06 (freedom from pinholes), and biocompatibility standards (ISO 10993-10, 16 CFR 1500).

Technological Characteristics

Nitrile rubber; ambidextrous; beaded cuff; non-sterile; polymer coated or chlorinated. Meets ASTM D6319-10, ASTM D5151-06, and ASTM D6124-06. Biocompatible per ISO 10993-10 and 16 CFR 1500.

Indications for Use

Indicated for use as a disposable medical glove worn on the examiner's hand to prevent contamination between patient and examiner. No specific patient population or contraindications described.

Regulatory Classification

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.

Predicate Devices

• Powder Free Nitrile Examination Glove, White (Non-Colored) and Blue (Colored), Non-Sterile (K093500)
• Powder Free Nitrile Patient Examination Glove, Blue Colored and White (Non-Colored), Non-Sterile (K111772)

Submission Summary (Full Text)

{0}------------------------------------------------

### 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.: | [phone] |
|----------------|----------------|
| Fax No.: | [phone] |

#### 2.0 Contact Person:

| Contact: | Mr Alex Yoong |
|----------------|----------------|
| Telephone No.: | [phone] |
| Fax No .: | [phone] |

#### 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.

{1}------------------------------------------------

# 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:

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.

#### 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-<br>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<br>(as per ISO 10993-<br>10:2010) | Not a contact skin sensitizer |
| | Primary Skin<br>Irritation Test<br>(as per 16 CFR Part<br>1500) | 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.

{2}------------------------------------------------

### 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:-

{3}------------------------------------------------

WSM WEAR SAFE (MALAYSIA) SDN BHD

Substantial Equivalence Comparison Table

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

{4}------------------------------------------------

WSM WEAR SAFE (MALAYSIA) SDN BHD
Comment

Page 5 of 6 (Rev 4)

{5}------------------------------------------------

WSM WEAR SAFE (MALAYSIA) SDN BHD
(00000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000

·

Page 6 of 6 (Rev 4)

·

{6}------------------------------------------------

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

{7}------------------------------------------------

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 [phone] or [phone] 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

{8}------------------------------------------------

# 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*

Page 1 of _