(67 days)
Not Found
Not Found
No
The summary describes a medical glove and does not mention any AI or ML capabilities, image processing, or data sets related to training or testing AI/ML models.
No
The device, a medical glove, is intended to prevent contamination between healthcare personnel and patients, not to treat a disease, injury, or condition.
No
The device is described as "Powdered Latex Examination Gloves" with the intended use of being "worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patient." This function is preventative, not diagnostic.
No
The device description clearly states it is "BLOSSOM™ Powdered Latex Examination Gloves," which are physical hardware. The summary does not mention any software component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to prevent contamination between healthcare personnel and the patient by being worn on the hand. This is a barrier function, not a diagnostic function performed in vitro (outside the body).
- Device Description: It's a medical glove. Gloves are physical barriers, not devices used to examine specimens or perform tests in vitro.
- 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 treatment decisions based on in vitro analysis.
The protein content labeling claim relates to potential allergic reactions, which is a safety characteristic of the device itself, not a diagnostic function.
N/A
Intended Use / Indications for Use
A medical glove is worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patient.
Product codes
LYY
Device Description
BLOSSOM™ Powdered Latex Examination Gloves with Protein Content Labeling Claim (100 micrograms or less of total water extractable Protein per gram).
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
Hand
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Health care and similar personnel
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)
Not Found
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.
0
Image /page/0/Picture/1 description: The image is a black and white circular logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around the perimeter. In the center of the circle is a stylized image of an eagle with its wings spread, a common symbol used in American government seals and logos. The eagle is depicted in a simple, graphic style, with bold lines forming its body and wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 9 1999
Mr. Tim Thai Vice President Mexpo International, Incorporated 2671 McCone Avenue ਰੇ 4 5 4 5 4 5 4 5 4 5 4 5 4 5 4 5 4 5 4 5 4 5 4 5 6 6 5 6 5 5 6 5 5 6 5 5 6 5 5 6 5 5 6 5 5 6 5 5 6 5 5 6 5 5 6 5 5 6 5 5 6 5 5 6 5 5 6 5 5 6 5 5 6 5 6 6 5 6 6 5 6 6 5 6 6 Hayward, California
Re : K990210
Blossom™ Powdered Latex Examination Gloves Trade Name: with Protein Content Labeling Claim (100 micrograms or less) Requlatory Class: I Product Code: LYY January 19, 1999 Dated: January 21, 1999 Received:
Dear Mr. Thai:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action.
1
Page 2 - Mr. Thai
through 542 of the Act for devices under the Electronic enrough Siz on Control provisions, or other Federal laws or requlations.
This letter will allow you to begin marketing your device as described in your 510 (k) premarket notification. The FDA deborizoof substantial equivalence of your device to a legally marketed predicate device results in a classification for your marice 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other qeneral information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address
"http://www.fda.gov/cdrh/dsma/dsmamai.n.html".
Sincerely yours,
Timothy A. Ulatowski
Director
Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
3.0 Indications for Use Statement: Include the following or equivalent Indications for Use page. The information, data and labeling claims in the entire the 510(k) submission must support and agree with the Indications for Use statement.
INDICATIONS FOR USE
| Applicant: | Mexpo International Inc. |
|---|---|
| 510(k) Number (if known): | |
| Device Name: | BLOSSOM™ Powdered Latex Examination Gloves |
| Indications For Use: | With Protein Content Labeling Claim (100 micrograms or less of total water extractable Protein per gram). A medical glove is worn on the hand of health care and |
similar personnel to prevent contamination between health care personnel and the patient.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH Office of Device Evaluation (ODE)
Qliss S. Lain
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital 510(k) Number
Prescription Use Per 21 CFR 801.109 OR
Over-The-Counter X
(Optional Format 1-2-96)
- For a new submission, do NOT fill in the 510(k) number blank.