(120 days)
Not Found
Not Found
No
The 510(k) summary describes a simple medical glove and contains no mention of AI, ML, or related concepts.
No
The device is described as a glove intended to prevent contamination, which is a protective rather than a therapeutic function.
No
Explanation: The device is described as a latex examination glove, intended for preventing contamination between patient and examiner. Its function is protective and hygiene-related, not diagnostic.
No
The device is described as "Chlorinated Powder Free Latex Examination Gloves," which are physical hardware devices, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is described as "worn on the mcarear, achear and to prevent contamination between patient and examiner." This describes a physical barrier function for protection, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is described as "Chlorinated Powder Free Latex Examination Gloves." This is a physical barrier device.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting specific substances, or providing diagnostic information about a patient's health status.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or screening purposes. This description clearly falls outside of that definition.
N/A
Intended Use / Indications for Use
The latex examination gloves is a disposable devices intended for medical, dental and laboratory purposes that is worn on the mcarear, achear and to prevent contamination between patient and examiner.
Product codes
LYY
Device Description
Chlorinated Powder Free Latex Examination Gloves (Yellow)
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
medical, dental and laboratory purposes
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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the seal of the Department of Health and Human Services, USA. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three parallel lines forming the snake and staff. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged in a circular pattern around the caduceus.
Public Health Service
JUN 7 - 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Nurul Aisyah Kong Quality Assurance Manager Hartalega Sdn. Bhd. Lot 9, Jalan Kuang Bulan, Taman Kepong Industial Estate, 52100 Kuala Lumpur MALAYSIA
Re: K050277
Trade/Device Name: Chlorinated Powder Free Latex Examination Gloves (Yellow) Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYY Dated: May 26, 2005 Received: June 3, 2005
Dear Ms. Kong:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your ea your entermined 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 mendments, or to devices that have been reclassified in accordance with the provisions of Antichunches, or to devroos and Cosmetic Act (Act) that do not require approval of a premarket the rederal I vou, Drag, Drag, therefore, market the device, subject to the general approvin apprevailed (the Act. The general controls provisions of the Act include controls providens or the ristration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting (1 Mr.), it may be back of Federal Regulations, Title 21, Parts 800 to 898. In your device can or found in the be as nouncements concerning your device in the Federal Register.
1
Page 2 - Ms. Kong
Please be advised that FDA's issuance of a substantial equivalence determination does not Please oe advised that I DT is issuaires on that your device complies with other requirements Incall that I DAT has made a autes and regulations administered by other Federal agencies. of the Act of ally I oderal barrequirements, including, but not limited to: registration 1 ou must comply with an art any fabeling (21 CFR Part 801); good manufacturing practice and listing (21 CF R Pact 807), lability systems (QS) regulation (21 CFR Part 820); and if requirements as set form in the quality of control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will and w yourse of substantial equivalence of your device to a promatice notification. - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), If you desire specific at the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the may obtain other general misternational and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Jenice K. Michie OMD
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known): K050277
Device Name: Chlorinated Powder Free Latex Examination Gloves (Yellow)
Indications For Use:
The latex examination gloves is a disposable devices intended for medical, dental and laboratory purposes that is worn on the mcarear, achear and to prevent contamination between patient and examiner.
Prescription Use (Part 21 CFR 801 Subpart D)
11/12/11/2017 11:51:14
AND/OR
Over-The-Counter Use x (21 CFR 801 Subpart C)
17/13
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE.)
Shula P. Murphy, 6
Page 1 of ____________________________________________________________________________________________________________________________________________________________________
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number. K030277