(119 days)
Not Found
Not Found
No
The device is a simple examination glove and the summary contains no mention of AI or ML.
No.
The device is described as an examination glove intended to prevent contamination, not to treat a medical condition or restore a bodily function.
No
The device is described as examination gloves, which are used to prevent contamination, not to diagnose a condition.
No
The device is described as "Latex Examination Gloves," which are physical hardware devices, not software.
Based on the provided information, the B-Care Powder Free, Latex Examination Gloves are not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is "worn on examiner's hands or finger to prevent contamination between patient and examiner." This describes a barrier device used for protection during physical examination, not a device used to examine specimens in vitro (outside of the body) to diagnose a condition.
- Definition of IVD: IVDs are devices used to examine specimens such as blood, urine, or tissue, taken from the human body to provide information for diagnosis, monitoring, or screening. The description of the gloves does not align with this definition.
- Lack of IVD-related information: The provided text does not mention any processes related to analyzing biological samples, chemical reactions, or diagnostic procedures.
Therefore, the B-Care Powder Free, Latex Examination Gloves are classified as a medical device, specifically an examination glove, but not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The B-Care Powder Free, Latex Examination Gloves is a disposable device intended for medical purposes that is worn on examiner's hands or finger to prevent contamination between patient and examiner. (21 CFR 880.6250)
Product codes (comma separated list FDA assigned to the subject device)
LYY
Device Description
B-Care Powder Free, Latex Examination Gloves (with protein label claim, 50 mg. or less)
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hands or finger
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): 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).
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes representing the three levels of government: federal, state, and local. The eagle is surrounded by a circular border with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" written around it.
SEP 2 7 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Rujira Phanphiphat General Manager B-Care Industries Company Limited 11 Chotiwitayakul 3 Road Hatyai, Songkhla, THAILAND 90110
Re: K051404
Trade/Device Name: B-Care Powder Free, Latex Examination Gloves (with protein label claim, 50 mg. or less) Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: 1 Product Code: LYY Dated: September 19, 2005 Received: September 19, 2005
Dear Ms. Phanphiphat:
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.
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 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 Eederal Register.
1
Page 2 - Ms. Phanphiphat
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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact 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 Division of Small Manufacturers, International 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,
Clive
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
Image /page/2/Picture/0 description: The image shows the logo for B-Care Industries Co. LTD. The logo features a stylized letter B with a hand inside of it. The text "-Care" is written in a bold, sans-serif font to the right of the B. The words "INDUSTRIES CO. LTD" are written in a smaller font below the "-Care" text.
11 Chotivitayakui 3 road, Hatýai, Songkhla , Thailand 90110 Tel : +66-(0)74-559501-6, Fax: +66-(0)74-559500
510(K) Pre market Notification
Patient Examination Gloves, Latex, Powder free, B-Care Powder Free Latex
Examination Glove Description
Attachment
Section
3.0
Indication for Use:
N/A
B-Care Industries Co.,Ltd. 510(k) number [K051409] Device name : B-Care Powder Free, Latex Examination Gloves (with protein label claim.50 ug. or less)
The B-Care Powder Free, Latex Examination Gloves is a disposable device intended for medical purposes that is worn on examiner's hands or finger to prevent contamination between patient and examiner. (21 CFR 880.6250)
Shule M. Murgulur KD 9/22/05
(Division Sign-Off) (Division Sign-Off)
Division of Anesthesiology, General Hospital,
Division of Anesthesiology, General Devices Division of Anton Dental Devices
510(k) Number: K051404
Prescription Use _________
AND/OR
Over-The-Counter Use × (21 CFR 807 Subpart C)
(Part 21 CFR 801Subpart D)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEED)
Concurrence of CDRH, Office of Device Evaluation (ODE)