(239 days)
Not Found
Not Found
No
The device description and intended use clearly indicate a physical barrier device (examination gloves) with no mention of software, data processing, or AI/ML terms.
No
The device, latex examination gloves, is intended to prevent contamination between the patient and examiner, which is a barrier function, not a therapeutic one. It does not treat or cure any medical condition.
No
Explanation: The device is described as an examination glove used to prevent contamination, not to diagnose a medical condition.
No
The device description clearly states it is a physical product (latex examination gloves) and does not mention any software components.
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 patient and examiner by being worn on the hand or finger. This is a physical barrier function, not a diagnostic test performed on samples taken from the body.
- Device Description: It's described as latex examination gloves, which are a physical barrier device.
- Lack of IVD Characteristics: There is no mention of:
- Analyzing samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening based on sample analysis.
IVDs are devices used to examine specimens derived from the human body to provide information for diagnostic purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
Intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
The latex examination gloves are used in both the Medical & Dental Communities, to prevent contamination between patient and examiner.
Product codes (comma separated list FDA assigned to the subject device)
Lyy
Device Description
Latex examination gloves - ambidextrous Comparative Chart
| Marsin | Safeskin | |
|---|---|---|
| ASTM D 5712 | completed | same |
| ASTM 3578-91 | Completed | same |
| Glove | Latex | same |
| Low Protein | ≤ 50 Micrograms | same |
| Intended Use | Examination | same |
| Packaging | 100 Pack dispenser | same |
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 Communities
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.
Safeskin Satin Plus Latex Examination Gloves
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
510(K) SUMMARY (as required by 807.92(c))
MAY 20 1998
Submitter of 510(k):
Regulatory & Marketing Services, Inc. (RMS) 40178 U.S. 19 North Tarpon Springs, FL 34689
813-942-3908 Phone: 813-942-3828 Fax:
Contact Person:
Ed Ransom
Date of Summary:
Trade Name:
Classification Name:
Predicate Device:
Device Description/ Comparison:
August 18, 1997
SkinGard TPF AOSSTEX TPF SensiFree Essential TPF Amerglo TPF
Latex Examination Gloves
Safeskin Satin Plus Latex Examination Gloves
Latex examination gloves - ambidextrous Comparative Chart
| Marsin | Safeskin | |
|---|---|---|
| ASTM D 5712 | completed | same |
| ASTM 3578-91 | Completed | same |
| Glove | Latex | same |
| Low Protein | ≤ 50 Micrograms | same |
| Intended Use | Examination | same |
| Packaging | 100 Pack dispenser | same |
Intended Use:
Intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of the department's name arranged in a circular fashion around a symbol. The symbol is a stylized representation of a human figure, with three overlapping profiles facing to the right, and a flowing, ribbon-like element beneath them.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 20 1998
Marcon Rubber Industrial, Incorporated ·C/O Mr. Ed Ransom Regulatory & Marketing Services, Incorporated (RMS) 3234 Ella Lane New Port Richey, Florida 34655
Re : K973615 SkinGard TPF/AOSSTEX TPF/SensiFree/Essential Trade Name: TPF/Ameriglo TPF Powder-Free Latex Examination Gloves with Protein Content Labeling Claim (50 Micrograms or Tess) Regulatory Class: I Product Code: Lyy Dated: April 28, 1998 Received: April 29, 1998
Dear Mr. Ransom:
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 regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਸ਼ੁ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, 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 action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531
2
Page 2 - Mr. Ransom
through 542 of the Act for devices under the Electronic Product Radiation 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 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 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 general 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/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
510(k) Number (if known): K973615
Device Name: Powder-Free
A Latex Examination Gloves WITH PROTEIN CONTENT LABELING
CLAIM (50 MICROGRAMS OR LESS)
Proprietary Names:
SkinGard TPF
AOSSTEX TPF
SensiFree
Essential TPF
Amerglo TPF
Indications For Use:
The fatex examination gloves are used in both the Medical & Dental Communities, to prevent contamination between patient and examiner.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH; Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use
(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devicon
$100
and General Hospital Infect
510(k) Number
(Optional Format 1-2-96)