POWDER FREE NITRILE EXAMINATION GLOVE, BLUE (Colored).

K142862 · Careplus (M) Sdn Bhd · LZA · Jan 16, 2015 · General Hospital

Device Facts

• Record ID: K142862
• Device Name: POWDER FREE NITRILE EXAMINATION GLOVE, BLUE (Colored).
• Applicant: Careplus (M) Sdn Bhd
• Product Code: LZA · General Hospital
• Decision Date: Jan 16, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Indications for Use

A 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.

Device Story

Disposable nitrile examination glove; blue colored; powder-free. Manufactured via on-line polymer-coating and chlorination process to modify surface characteristics, ensuring tack-free finish without dusting powder. Used in clinical settings by healthcare professionals to provide a barrier against contamination between patient and examiner. Benefits users sensitive to powdered gloves or those requiring a powder-free environment. Device is non-sterile.

Clinical Evidence

Bench testing only. Device performance verified against ASTM D6319-10 (dimensions, physical properties), ASTM D5151-06 (water tightness), and ASTM D6124-06 (powder residue). Biocompatibility testing conducted per ISO 10993-10 (dermal sensitization) and 16 CFR Part 1500 (primary skin irritation), confirming the material is not a sensitizer or irritant.

Technological Characteristics

Material: Nitrile. Form factor: Disposable examination glove. Surface treatment: On-line polymer-coating and chlorination. Standards: ASTM D6319-10, ASTM D5151-06, ASTM D6124-06, ISO 10993-10, 16 CFR Part 1500. Non-sterile.

Indications for Use

Indicated for use as a disposable medical glove worn on the examiner's hand or finger to prevent cross-contamination between patient and examiner.

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 Blue and White Colored, Nonsterile (K123469)

Submission Summary (Full Text)

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

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with the profiles overlapping each other.

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

January 16, 2015

Careplus (M) SDN BHD Mr. Lim Kwee Shyan Managing Director Lot 120 & 121 Jalan Senawang 3 Senawang Industrial Estate 70450 Seremban Negeri Sembilan Darul Khusus MALAYSIA

Re: K142862

Trade/Device Name: Powder Free Nitrile Examination Glove, Blue (Colored) Regulation Number: 21 CFR 880.6250 Regulation Name: Patient examination glove Regulatory Class: I Product Code: LZA Dated: December 1, 2014 Received: December 3, 2014

Dear Mr. Shyan:

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.

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

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 contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

**Tejashri Purohit-Sheth, M.D.**

Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR

Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

## Indications for Use

510(k) Number (if known): K142862

Device Name: Powder Free Nitrile Examination Glove, Blue (Colored)

Indications for Use: A 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.

Prescription Use Over-The-Counter Use X AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

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

Image /page/3/Picture/0 description: The image is a logo with a white square background. Inside the square, there is a gray vertical rectangle on the left side and a red semi-circle on the right side. The semi-circle is positioned such that it forms the letter 'P' when combined with the gray rectangle. There is a black shadow underneath the square.

### AREPLUS (M) SDN BHD (Company No. 212677-K)

ng Industrial Estate, 70450 Seremban, Negeri Sembilan Darul Khusus. Malaysia. Fax: [phone] Tel: [phone]

E-mail: [e-mail]

Quality and Relationship You Can Trust

## 510(K) SUMMARY

510(k) No.: K142862

- CAREPLUS (M) SDN BHD 1.0 Applicant: Address: Lot 120 & 121 , Jalan Senawang Senawang Industrial Estate,
70450 Seremban, Negeri Sembilan Darul Khusus. Malaysia.

- Phone No.: 60-6-6772781 Fax No. 60-6-6772780
- 2.0 Lim Kwee Shvan Contact Person: Phone No.: 60-6-6772781 Fax No. 60-6-6772780
- Preparation Date: 16th January, 2015 3.0
- 4.0 Device Information

Device Name: POWDER FREE NITRILE EXAMINATION GLOVE, BLUE(COLORED) Common Name: POWDER FREE NITRILE EXAMINATION GLOVE Classification Name: Patient Examination Gloves

#### 5.0 Claim of Equivalence

The device is a class I latex patient examination gloves 21 CFR 880.6250, Patient Examination Glove, LZA which is made powder-free by a process of on-line polymercoating and chlorination which is substantially equivalent in safety and effectiveness to the predicate device Powder Free Nitrile Examination Glove Blue and White Colored, Nonsterile 510(k) number K123469, product code LZA.

- 6.0 Device Description
It is the powder-free variation of the class I latex patient examination gloves made by online polymer-coating and on-line chlorination process. The process modifies the surface characteristics and causes it to remain tack-free without the use of any dusting or donning powder. It is particularly suitable to users who prefer a powder-free work environment or who may be sensitive to the powdered version of the same gloves.

- 7.0 Intended Use of Device
A 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.

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

Image /page/4/Picture/0 description: The image is a logo that features a square with a thick black border. Inside the square, there is a gray vertical rectangle on the left side and a red semi-circle on the right side. The semi-circle is positioned so that its flat edge aligns with the right edge of the gray rectangle, creating a shape that resembles the letter 'P'.

# CAREPLUS (M) SDN BHD (company No. 212677-K)

Lot 120 & 121, Jalan Senawang 3, Senawang Industrial Estate, 70450 Seremban, Negeri Sembilan Darul Khusus, Malaysia. Tel: [phone] Fax: [phone]

E-mail: [e-mail]

Quality and Relationship You Can Trust

#### 8.0 1)Comparison To Predicate Device

| No. | Characteristic | Standards | Related Defects | Predicate Device<br>(Powder Free Nitrile<br>Examination Glove,<br>Blue and White<br>Colored K123469) | Powder-Free Nitrile<br>Examination Glove<br>(Blue Color) |
|-----|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------|--------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1 | Water Tight Test,<br>1000 ml | ASTM D6319-10<br>ASTM D5151-06 | G- I, AQL<br>2.5<br>(FDA GII,<br>AQL 2.5) | Meets ASTM D6319-10<br>Meets ASTM D5151-06 | Meets ASTM D6319-10<br>Meets ASTM D5151-06 |
| 2 | Physical Properties<br>(Before Ageing)<br>i) Tensile Strength(Mpa)<br>ii)Ultimate Elongation(%)<br>(After Ageing)<br>i) Tensile Strength(Mpa)<br>ii) Ultimate Elongation(%) | ASTM D6319-10 | Min. 14<br>Min. 500<br><br>Min. 14<br>Min. 400 | Meets ASTM D6319-10<br>Meets ASTM D6319-10<br><br>Meets ASTM D6319-10<br>Meets ASTM D6319-10 | Meets ASTM D6319-10<br>Meets ASTM D6319-10<br><br>Meets ASTM D6319-10<br>Meets ASTM D6319-10 |
| 3 | Powder Content | ASTM D6319-10<br>ASTM D6124-06 | Max.<br>2mg/glove | Meets ASTM D6319-10<br>Meets ASTM D6124-06 | Meets ASTM D6319-10<br>Meets ASTM D6124-06 |
| 4 | Biocompatibility Test<br><br>i) Primary Skin Irritation<br>Test<br><br>ii)Dermal Sensitization<br>Test | ISO 10993-10<br><br>As per 16CFR<br>Part 1500 | No Animal<br>Irritation<br><br>No Animal<br>Irritation | Passes<br>i) Primary Skin<br>Irritation Test.<br>Conclusion: Under the<br>conditions of this study,<br>the test material did not<br>cause an irritant<br>response.<br><br>ii)Dermal Sensitization<br>Test.<br>Conclusion: Under the<br>conditions of this study,<br>the test material did not<br>produce a skin<br>sensitization effect. | Passes<br>i) Primary Skin Irritation Test.<br>Conclusion: Under the<br>conditions of this study,<br>the test material did not<br>cause an irritant<br>response.<br><br>ii)Dermal Sensitization<br>Test.<br>Conclusion: Under the<br>conditions of this study,<br>the test material did not<br>produce a skin<br>sensitization effect. |
| 5 | Color Extraction | | | Blue | Blue |

### Conclusions:

Careplus (M) Sdn Bhd, Powder Free Nitrile Examination Glove, Blue (colored) is similar with Wear Safe (M) Sdn Bhd, Powder Free Nitrile Examination Glove, Blue and White Colored, K123469.

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

Image /page/5/Picture/0 description: The image is a logo that features a square divided into two distinct sections. On the left side, there is a gray vertical rectangle. On the right side, there is a red semi-circle. The logo has a simple and modern design, using only two colors and basic geometric shapes.

# CAREPLUS (M) SDN BHD (company No. 212677-K)

Lot 120 & 121, Jalan Senawang 3, Senawang Industrial Estate, 70450 Seremban, Negeri Sembilan Darul Khusus, Malaysia. Tel: [phone] Fax: [phone]

E-mail: [e-mail]

Quality and Relationship You Can Trust

## 2) Summary of Technological Characteristics of the Device

Powder Free Nitrile Examination Glove, Blue(Colored) possesses the following technological characteristic (as compared to ASTM or equivalent standards):

| Parameter | Standard References | Device Performance |
|------------------------|-------------------------------------------------------------|----------------------------------|
| Dimensions | ASTM D6319-10 | Meet Specification |
| Physical Properties | ASTM D6319-10 | Meet Specification |
| Freedom from pin-holes | ASTM D5151-06 | Meet Specification |
| Powder Free Residue | ASTM D6124-06 | Meet Specification |
| | ASTM D6319-10 | Meet Specification |
| Biocompatability Test | Dermal Sensitization<br>Test<br>(ISO 10993-10:2010) | Not a contact skin<br>sensitizer |
| | Primary Skin Irritation<br>Test<br>(As per 16CFR Part 1500) | Not a primary skin<br>irritant |

#### 9.0 Conclusion

Powder Free Nitrile Examination Glove, Blue(Colored) performs according to the glove performance standards referenced in Section 8.0 above. The device is substantially equivalent to current marketed devices per Section 5.0.