Polyisoprene Powder Free Surgical Glove, Polyisoprene Powder Free Surgical Underglove

K183389 · Hartalega NGC Sdn. Bhd. · KGO · Jun 28, 2019 · General, Plastic Surgery

Device Facts

• Record ID: K183389
• Device Name: Polyisoprene Powder Free Surgical Glove, Polyisoprene Powder Free Surgical Underglove
• Applicant: Hartalega NGC Sdn. Bhd.
• Product Code: KGO · General, Plastic Surgery
• Decision Date: Jun 28, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4460
• Device Class: Class 1

Intended Use

The Polyisoprene Powder Free Surgical Glove is a disposable device that is intended to be worn the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminations. The Polyisoprene Powder Free Surgical Underglove is a disposable device that is intended to be worn the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminations.

Device Story

Polyisoprene powder-free surgical gloves and undergloves; disposable; worn on hands by healthcare personnel in surgical settings; provide barrier protection against infectious materials and contaminants. Device functions as physical barrier; no electronic or algorithmic components.

Clinical Evidence

Bench testing only.

Technological Characteristics

Material: Polyisoprene. Form factor: Disposable surgical glove/underglove. Powder-free. Non-sterile/sterile (implied by surgical designation). No electronic components or software.

Indications for Use

Indicated for use by healthcare personnel in surgical settings as a protective barrier against infectious materials and contaminants.

Regulatory Classification

Identification

A non-powdered surgeon's glove is a device intended to be worn on the hands of operating room personnel to protect a surgical wound from contamination. A non-powdered surgeon's 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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June 28, 2019

Hartalega NGC Sdn. Bhd. Nurul Aisyah Kong Quality Assurance Senior Manager Dataran Sd Pju 9 Bandar Sri Damansara, 52200 My

Re: K183389

Trade/Device Name: Polyisoprene Powder Free Surgical Glove, Polyisoprene Powder Free Surgical Underglove Regulation Number: 21 CFR 878.4460 Regulation Name: Non-Powdered Surgeon's Glove Regulatory Class: Class I Product Code: KGO Dated: May 31, 2019 Received: June 3, 2019

Dear Nurul Aisyah 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 or any Federal

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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

For Elizabeth Claverie-Williams, M.S. Assistant Director THT4B2: Disinfection, Reprocessing and Personal Protection Acting Assistant Director,THT4B1: Sterility Devices DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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

## Indications for Use

510(k) Number (if known) K183389

Device Name Polyisoprene Powder Free Surgical Glove

Indications for Use (Describe)

The Polyisoprene Powder Free Surgical Glove is a disposable device that is intended to be worn the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminations.

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

Prescription Use (Part 21 CFR 801 Subpart D)

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

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FORM FDA 3881 (7/17)

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

## Indications for Use

510(k) Number (if known) K183389

Device Name

Polyisoprene Powder Free Surgical Underglove

Indications for Use (Describe)

The Polyisoprene Powder Free Surgical Underglove is a disposable device that is intended to be worn the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminations.

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

Prescription Use (Part 21 CFR 801 Subpart D)

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

### CONTINUE ON A SEPARATE PAGE IF NEEDED.

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 data 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 PRAStaff(@fda.hhs.gov

"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 (7/17)

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.