NITRILE POWDER FREE EXAMINATION GLOVE (ABLU)

K130473 · Hartalega Sdn Bhd · LZA · Jul 5, 2013 · General Hospital

Device Facts

• Record ID: K130473
• Device Name: NITRILE POWDER FREE EXAMINATION GLOVE (ABLU)
• Applicant: Hartalega Sdn Bhd
• Product Code: LZA · General Hospital
• Decision Date: Jul 5, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

The Nitrile Powder Free Examination Glove is a non - sterile disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.

Device Story

Nitrile powder-free examination gloves; non-sterile; disposable. Worn on examiner's hands; barrier protection against cross-contamination between patient and examiner. Used in clinical settings. Available in multiple colors (Aqua Blue, Orange, Black) and cuff lengths (standard and extended).

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Nitrile rubber material; powder-free; non-sterile; disposable; various colors and cuff lengths. Class I medical device.

Indications for Use

Indicated for use as a non-sterile, disposable patient examination glove worn by healthcare examiners to prevent cross-contamination between the examiner and the patient.

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)

{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 stylized symbol resembling a bird or abstract human figure, accompanied by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" arranged in a circular fashion around the symbol. The symbol is composed of three curved lines that create a sense of movement or flow.

#### Public Health Service

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

July 5, 2013

Hartalega Sdn. Bhd. Ms. Nurul Aisyah Kong Quality Assurance Senior Manager No. 7 Kawasan Persusahaan Suria 45600 Bestari Jaya SELANGOR Malaysia

Re: K130473

Trade/Device Name: Nitrile Powder Free Examination Glove (Aqua Blue) Nitrile Powder Free Examination Glove (Aqua Blue)-Extended Cuff Nitrile Powder Free Examination Glove (Orange) Nitrile Powder Free Examination Glove (Orange)-Extended Cuff Nitrile Powder Free Examination Glove (Black) Nitrile Powder Free Examination Glove (Black)- Extended Cuff Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: April 12, 2013

Received: April 15, 2013

#### 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 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

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

Page 2 - Ms. Kong

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.

f

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 toll-free number [phone] or [phone] or at its Internet address

http://www.fdagov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Image /page/1/Picture/8 description: The image shows a document with the text "Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID FOR". The text is in a formal font and appears to be part of an official document. There is also a signature on the left side of the image.

Kwame Ulmer M.S. Acting Division Director Division of Anesthesiology, General Hospital Respiratory, Infection Control and Dental Device Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

510(k) Number (if known): K130473

Device Name:

Nitrile Powder Free Examination Glove (ABLU)

*Note: ABLU = Aqua Blue.

Indication for Use:

The Nitrile Powder Free Examination Glove is a non - sterile disposable device intended for medical purpose 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 X (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Elizabeth F 2013.06.28 27:

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices 510(k) Number: ___K130473

Page of of _

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

510(k) Number (if known): K130473

Device Name:

Nitrile Powder Free Examination Glove (ABLU) - Extended Cuff

*Note: ABLU = Aqua Blue.

Indication for Use:

The Nitrile Powder Free Examination Glove is a non - sterile disposable device intended for medical purpose 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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Elizabeth Claverie
2013.06.28 21:09:33 -04'00'

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices 510(k) Number: __K130473

Page of

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

510(k) Number (if known): K130473

Device Name:

Nitrile Powder Free Examination Glove (Orange)

Indication for Use:

The Nitrile Powder Free Examination Glove is a non - sterile disposable device intended for medical purpose 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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Image /page/4/Picture/11 description: The image shows the name "Elizabeth F. Claverie" in a clear, sans-serif font. Below the name, there is a date and time stamp that reads "2013.06.28 21:10:04 -04'00'". The date format appears to be year, month, and day.

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices 510(k) Number: __K130473

Page

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

510(k) Number (if known): K130473

Device Name:

Nitrile Powder Free Examination Glove (Orange) - Extended Cuff

Indication for Use:

The Nitrile Powder Free Examination Glove is a non - sterile disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.

Prescription Use (Part 2) CFR 801 Subpart D)

AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Elizabeth 2013.06.28 2

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices 510(k) Number: K130473

Page __ of _

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

510(k) Number (if known): K130473

Device Name:

Nitrile Powder Free Examination Glove (Black)

Indication for Use:

The Nitrile Powder Free Examination Glove is a non - sterile disposable device intended for medical purpose 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 ਮ (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Elizabeth F 2013.06.28 2

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices 510(k) Number: K130473

Page __ of _

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

510(k) Number (if known): K130473

Device Name:

Nitrile Powder Free Examination Glove (Black) - Extended Cuff

Indication for Use:

The Nitrile Powder Free Examination Glove is a non - sterile disposable device intended for medical purpose 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 ਮ (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Elizabeth F 2013.06.28

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices . 510(k) Number: __K130473

Page __ of ___________________________________________________________________________________________________________________________________________________________________