K Number
K140050
Device Name
NITRILE POWDER FREE EXAMINATION GLOVE WITH COLLOIDAL OATMEAL USP SKIN PROTECTANT DRUG - DKBU /DARK BLUE
Manufacturer
Date Cleared
2014-09-12

(246 days)

Product Code
Regulation Number
880.6250
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Nitrile Powder Free Examination Gloves with Colloidal Oatmeal USP Skin Protectant - Blue (DKBU) is a non-sterile disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination betwreen patient and examiner. The Nittile Powder Free Examination Gloves with Colloidal Oatmeal USP Skin Protectant - Blue (Dawn Blue) is a nonsterile disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
Device Description
Nitrile Powder Free Examination Gloves with Colloidal Oatmeal USP Skin Protectant - Blue (DKBU) and Nitrile Powder Free Examination Gloves with Colloidal Oatmeal USP Skin Protectant - Blue (Dawn Blue)
More Information

Not Found

Not Found

No
The 510(k) summary describes examination gloves, a simple barrier device, and contains no mention of AI, ML, image processing, or any other technology typically associated with AI/ML applications in medical devices.

No
A therapeutic device is one that treats or rehabilitates a condition. This device is a glove intended to prevent contamination, which is a prophylactic measure, not a therapeutic one.

No
Explanation: The device is described as an examination glove intended to prevent contamination between patient and examiner, not to diagnose a condition.

No

The device description clearly states it is a physical glove worn on the hand, which is a hardware component, not software.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use clearly states the device is "worn on the examiner's hand to prevent contamination between patient and examiner." This describes a barrier device used externally on the body.
  • IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, tissue) to detect diseases, conditions, or infections. This device does not perform any such testing.
  • Lack of IVD Characteristics: The description lacks any mention of analyzing biological samples, detecting analytes, or providing diagnostic information.

Therefore, the Nitrile Powder Free Examination Gloves with Colloidal Oatmeal USP Skin Protectant are considered a medical device, but not an in vitro diagnostic device.

N/A

Intended Use / Indications for Use

The Nitrile Powder Free Examination Gloves with Colloidal Oatmeal USP Skin Protectant - Blue (DKBU) is a non-sterile disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination betwreen patient and examiner.

The Nittile Powder Free Examination Gloves with Colloidal Oatmeal USP Skin Protectant - Blue (Dawn Blue) is a nonsterile disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.

Product codes (comma separated list FDA assigned to the subject device)

LYZ

Device Description

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Mentions image processing

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Mentions AI, DNN, or ML

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Input Imaging Modality

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Anatomical Site

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Indicated Patient Age Range

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Intended User / Care Setting

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Description of the training set, sample size, data source, and annotation protocol

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Description of the test set, sample size, data source, and annotation protocol

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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

Not Found

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

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§ 880.6250 Non-powdered patient examination glove.

(a)
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.(b)
Classification. Class I (general controls). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.

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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" around the perimeter. Inside the circle is an abstract symbol featuring three stylized human profiles facing to the right, resembling a bird-like shape.

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

September 12, 2014

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

Re: K140050

Trade/Device Name: Nitrile Powder Free Examination Gloves with Colloidal Oatmeal USP Skin Protectant - Blue (DKBU) and Nitrile Powder Free Examination Gloves with Colloidal Oatmeal USP Skin Protectant - Blue (Dawn Blue) Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYZ Dated: August 15, 2014 Received: August 18, 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 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.

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Page 2 - Ms. Kong

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 (800) 638-2041 or (301) 796-7100 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" (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 (800) 638 2041 or (301) 796-7100 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

2

ATTACHMENT 1.0

:

:

.

INDICATION FOR USE STATEMENT

3

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) K140050

Device Name

Nitrile Powder Free Examination Gloves with Colloidal Oatmeal USP Skin Protectant - Blue (DKBU)

Indications for Use (Describe)

The Nitrile Powder Free Examination Gloves with Colloidal Oatmeal USP Skin Protectant - Blue (DKBU) is a non-sterile disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination betwreen patient and examiner.

*Note: DKBU is Dark Blue

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

Prescription Use (Part 21 CFR 801 Subpart D)

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

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

NATURE AND AND AND FOR FOR FOR FOR FOR FOR FOR A BROAD A BROAD A BROAD

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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 (1/14)

4

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) K140050

Device Name

Nitrile Powder Free Examination Gloves with Colloidal Oatmeal USP Skin Protectant - Blue (Dawn Blue)

Indications for Use (Describe)

The Nittile Powder Free Examination Gloves with Colloidal Oatmeal USP Skin Protectant - Blue (Dawn Blue) is a nonsterile disposable device 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)

ا Prescription Use (Part 21 CFR 801 Subpart D)

اليل 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 FDA USE ONLY CONSEE ONLY CONSULTION

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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 (1/14)