(107 days)
Not Found
Not Found
No
The device is a simple examination glove and the summary contains no mention of AI, ML, or related technologies.
No
The device is an examination glove, worn to prevent contamination, not to provide therapy or treatment.
No
Explanation: The device, a nitrile examination glove, is intended to prevent contamination and is worn on the examiner's hand. It does not perform any diagnostic function.
No
The device described is a physical examination glove, which is a hardware medical device, 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 gloves are "worn on the examiner's hand to prevent contamination between patient and examiner." This is a barrier function, not a diagnostic function performed in vitro (outside the body) on specimens.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens (blood, urine, tissue, etc.)
- Detecting or measuring substances in specimens
- Providing information for diagnosis, monitoring, or screening
The device is a medical device, specifically an examination glove, but its purpose is protective and preventative, not diagnostic.
N/A
Intended Use / Indications for Use
The Nitrile Powder Free Examination Glove - Cobalt Blue (CBLU) 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
The Nitrile Powder Free Examination Glove - Dark Violet Blue (DVBU) 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
The Nitrile Powder Free Examination Glove - Dawn Blue is a non - sterile disposable device intended for medical purpost that is worn on the examiner's hand to prevent contamination between patient and examiner
The Nittile Powder Free Examination Glove - White is a non - sterile disposable device intended for medical puppose that is wom on the examiner's hand to prevent contamination between patient and examiner
Product codes
LZA
Device Description
Nitrile Powder Free Examination Glove - White
Nitrile Powder Free Examination Glove - Dawn Blue
Nitrile Powder Free Examination Glove - Dark Violet Blue (DVBU)
Nitrile Powder Free Examination Glove - Cobalt Blue (CBLU)
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hand
Indicated Patient Age Range
Not Found
Intended User / Care Setting
examiner
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-000
July 24, 2014
Hartalega NGC Sdn Bhd Ms. Nurul Aisyah Kong Quality Assurance- Senior Manager No. 1 Persiaran Tanjung Lot PT4330 Kawasan Perindustrian Tanjung Jalan B20, 64000 Sepang Selangor Darul Ehsan, Malaysia
| Re: | K140890 |
|---|---|
| Trade/Device Name: | Nitrile Powder Free Examination Glove - White |
| Nitrile Powder Free Examination Glove - Dawn Blue | |
| Nitrile Powder Free Examination Glove - Dark Violet Blue (DVBU) | |
| and | |
| Nitrile Powder Free Examination Glove - Cobalt Blue (CBLU) | |
| Regulation Number: | 21 CFR 880.6250 |
| Regulation Name: | Patient Examination Glove |
| Regulatory Class: | I |
| Product Code: | LZA |
| Dated: | April 23, 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 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
Page 2 - Ms. Nurul Aisyah 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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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" (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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours. Teiashri Puroki 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
·
. ATTACHMENT 1.0
INDICATION FOR USE STATEMENT
.
Attachment 1.0 - 1
3
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
Nitrile Powder Free Examination Glove - Cobalt Blue (CBLU)
Indications for Use (Describe)
The Nitrile Powder Free Examination Glove - Cobalt Blue (CBLU) 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
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)
Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See PRA Statement below.
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 Terrell A. Cunningham |
| Date: 2014.07.23-20:00:20-04'00' |
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 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)
PSC Pcblickling Screices (301) 443-6740
4
| DEPARTMENT OF HEALTH AND HUMAN SERVICES |
|---|
| Food and Drug Administration |
Indications for Use
510(k) Number (if known)
Device Name
Nitrile Powder Free Examination Glove - Dark Violet Blue (DVBU)
Indications for Use (Describe)
The Nitrile Powder Free Examination Glove - Dark Violet Blue (DVBU) 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
Type of Use (Selact one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
[2] 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 Terrell A. Cunningham - |
| Date: 2014.07.23 19:59:35 -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 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
"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)
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 (if known) | |
|---|---|
| -------------------------- | -- |
Device Name
Nitrile Powder Free Examination Glove - Dawn Blue
Indications for Use (Describe)
The Nitrile Powder Free Examination Glove - Dawn Blue is a non - sterile disposable device intended for medical purpost 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 Subpan 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 signe unningham -S Date: 2014.07
This section applies only to requirements of the Paperwork Reduction Act of 1985.
*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 callection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Dapartment 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)
6
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)
Devica Name
Nitrile Powder Free Examination Glove - White
Indications for Use (Describe)
The Nittile Powder Free Examination Glove - White is a non - sterile disposable device intended for medical puppose that is wom 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 FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Digitally signed b Cunningham -S Date: 2014.07.23 1修
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)
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