NITRILE POWDER FREE EXAMINATION GLOVE WITH COLLOIDAL OATMEAL USP SKIN PROTECTANT DRUG - WHITE / DAWN BLUE / LEMON GREEN

K133956 · Hartalega Sdn Bhd · LZA · May 28, 2014 · General Hospital

Device Facts

• Record ID: K133956
• Device Name: NITRILE POWDER FREE EXAMINATION GLOVE WITH COLLOIDAL OATMEAL USP SKIN PROTECTANT DRUG - WHITE / DAWN BLUE / LEMON GREEN
• Applicant: Hartalega Sdn Bhd
• Product Code: LZA · General Hospital
• Decision Date: May 28, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Indications for Use

The Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Skin Protectant - White (Lavender Scent) is a non - sterile disposable device intended for medical purpose that is worn on the examiner's hands to prevent contamination between patient and examiner. The Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Skin Protectant - Dawn Blue (Lavender Scent) is a non - sterile disposable device intended for medical purpose that is worn on the examiner's hands to prevent contamination between patient and examiner. The Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Skin Protectant - Lemon Green (Lavender Scent) is a non - sterile disposable device intended for medical purpose that is worn on the examiner's hands to prevent contamination between patient and examiner.

Device Story

Nitrile examination gloves coated with colloidal oatmeal USP skin protectant; non-sterile; disposable. Worn by healthcare examiners to provide a barrier against contamination between patient and examiner. Available in multiple colors (White, Dawn Blue, Lemon Green) and scented (Lavender).

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Nitrile rubber material; disposable; non-sterile; coated with colloidal oatmeal USP skin protectant; lavender scent added.

Indications for Use

Indicated for use as a non-sterile, disposable medical glove worn on the examiner's hands to prevent 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.

Submission Summary (Full Text)

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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" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

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

May 28, 2014

Hartalega Sdn. Bhd. Ms. Nurul Aisyah Kong Senior Manager - Quality Assurance No. 7. Kawasan Perusahaan Suria 45600 Bestari Jaya Selangor Darul Ehsan, Malaysia

Re: K133956

Trade/Device Name: Nitrile Powder Free Examination Glove with Colloidal Oatmeal Skin Protectant - White (Lavender Scent);

> Nitrile Powder Free Examination Glove with Colloidal Oatmeal Skin Protectant - Dawn Blue (Lavender Scent) and

> Nitrile Powder Free Examination Glove with Colloidal Oatmeal Skin Protectant - Lemon Green (Lavender Scent)

Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination glove Regulatory Class: 1 Product Code: LZA

Dated: April 25, 2014

Received: April 28, 2014

Dear Ms. Kong:

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 cither class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be

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Page 2 - Ms. Kong

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 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 Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/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 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,

Erin 1. Keith, M.S. Acting 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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# ATTACHMENT 1.0

# INDICATION FOR USE STATEMENT

Attachment 1.0 - 1

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## DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Explration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known) K133956

#### Device Name

Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Skin Protectant - White (Lavender Scart)

#### Indications for Use (Describe)

The Nitrile Power Free Examination Glove with Colloidal Ostmeal USP Skin Protectant - White (Lavender Scent) is a non - sterile disposable device interest of the Souther Soll Proceder - Willier (Larder Sceni) Is a between patient and examiner

Type of Use (Select one or both, as applicable)

J Prescription Use (Part 21 CFR 801 Subpart D)

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

# PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

| Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) | |
|------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Digitally signed by Sreekanth Gutala -S<br>DN: c=US, o=U.S. Government, ou=HHS,<br>ou=FDA, ou=People,<br>0.9.2342.19200300.100.1.1=2000540490<br>cn=Sreekanth Gutala -S<br>Date: 2014.05.23 14:54:40 -04'00 |
| Sreekanth<br>Gutala -S | |

This section applies only to requirements of the Paperwork Reduction Act of 1995.

# *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintein the data needed and complete and review the collection of Information. Send comments regarding this burden estimate or any other espect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number.

FORM FDA 3881 (1/14)

-

Page 1 of 1

POC Publicition Services [phone] 比

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# DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

## Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 -See PRA Statement below.

#### 510(k) Number (if known) K133956

#### Device Name

Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Skin Protectant - Dawn Blue (Lavender Scent)

# Indications for Use (Describe)

The Nitrile Powder Free Examination Glove with Colloidal Ostmed USP Skin Protectant - Dawn Blue (Lavender Scent) is a non - sterile disposable device intended for medical purpose that is worn on the examiner's hands to prevent contamination between patient and examiner

Type of Use (Salect one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

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

# PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FOR FOR FOR FOR FOR FOR USE ONLY : 11: 11:41:11:11: ... ... : Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

> sioned by Sneekanth Gutala - S =U.S. Government, our KHS People 300.100.1.1=2000540490. 5 ેન્ડર્મિક -2 વન્ડરીટ -0 LOLOCK
> GUTER -2 Sec. 1072 D

This section applies only to requirements of the Paperwork Reduction Act of 1995.

# *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, Including the and review the collection of leferm existing data sources, gather and melitizin the deta needed and complete and review the collection of information. Send comments regarding this burden estimate or any other spect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of Information unless it displays a currently valid OMB number, "

FORM FDA 3881 (1/14)

Page 1 of 1

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

## DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

### Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (ti known) K133956

#### Device Name

Nitrile Powder Free Examination Glove with Colloidal Oatment - Lemon Green (Lavender Seent)

#### Indications for Use (Describe)

The Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Skin Protectant - Lemon Green (Lavender Scent) is a non - sterile disposable dovice intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner

Type of Use (Select one or both, as applicable)

- Prescription Use (Part 21 CFR 801 Subpart D)

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

# PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FOR FDA USE ONLY CONLY CONTRACT A S. . . . . . . ... .. Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Image /page/5/Picture/13 description: The image shows the name "Sreekanth Gutala-S" in bold, black font on the left side of the image. On the right side of the image, there is a digital signature that reads "Digitally signed by Sreekanth Gutala-S". The signature also includes the date and time: 2014.05.23 14:55:29-04'00.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

# *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of Information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the deta needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agancy may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

FORM FDA 3881 (1/14)

Page 1 of 1

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