(256 days)
No
The device description and performance studies focus on the physical properties and barrier function of a medical glove, with no mention of AI or ML technology.
No.
The device, an examination glove, is intended to prevent contamination between patient and examiner, not to treat or cure a disease or condition.
No
The device is a glove, which creates a barrier to prevent contamination. It does not diagnose.
No
The device description clearly states it is a physical glove made of natural rubber latex, which is a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's a "disposable device intended for medical purposes that is worn on the examiners hand to prevent contamination between patient and examiner." This describes a barrier device used during physical examination or procedures, not a device used to examine specimens in vitro (outside the body) to diagnose a condition.
- Device Description: The description focuses on the physical properties of the glove (material, barrier function, tensile properties) and its manufacturing standards. It does not mention any components or processes related to analyzing biological samples.
- Lack of IVD Indicators: There is no mention of analyzing samples, reagents, assays, or any other elements typically associated with in vitro diagnostics.
Therefore, this device falls under the category of a medical device used for protection and barrier purposes, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Examination Glove is "a disposable device, intended for medical purposes, that is worn on the examiner's hand to prevent contamination between patient and examiner". Powder Free gloves are intended for use in situations where powder is not desirable.
Product codes
LYY
Device Description
Natural Rubber Latex films form a barrier to body fluids and bloodborne pathogens. The Natural rubber Is water tight under normal conditions of use. It's tensile properties cause it to conform to the hand, allowing movements necessary for medical treatment. Natural Rubber Latex is known to create a barrier to bloodborne pathogens and and body fluids. ASTM conforming tensile properties create a glove that is strong and flexible. The glove is manufactured in accordance with the requirements of ASTM D3578-95 and ASTM D5151-92.
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)
Non-clinical tests were performed based on PERFORMANCE STANDARDS: ASTM D3578-95 and WATER TIGHTNESS: ASTM D5151-92. Clinical tests for safety included: RABBIT IRRITATION: Passes and GUINEA PIG SENSITIZATION: Passes. The data summaries indicate that the proposed product meets or exceeds acceptable scores for the predicate product in nonclinical tests, and satisfies the requirements for a safe and effective medical glove.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
4/2/99
SUMMARY OF 510(k) SUBMISSION K982505
INFORMATION A. 1. SUBMITTER'S
- NAME:
ADDRESS:
TELEPHONE NUMBER:
CONTACT PERSON:
DATE SUMMARY PREPARED:
-
- NAME OF DEVICE TRADE OR PROPRIETARY NAME:
COMMON OR USUAL NAME:
- NAME OF DEVICE TRADE OR PROPRIETARY NAME:
CLASSIFICATION NAME:
- PREDICATE DEVICE IDENTIFICATION NAME, NUMBER
TILLOTSON HEALTHCARE CORPORATION
360 Route 101
Bedford, NH 03110 U.S.A.
(603) 472-6600
Edward Markovic
July 20, 1998
Ultra Care Non-Sterlie Powder Free (GREEN) Natural Rubber Latex Patient Examination Glove
Examination Glove
Examination Glove
Ultra Care Non-Sterile Powder Free Natural Rubber Latex Patient Examination Glove K960247 1.Substantially Equivalent to Devices being marketed in the United States.
4. DESCRIPTION OF DEVICE
- a. HOW THE DEVICE FUNCTIONS: Natural Rubber Latex films form a barrier to body fluids and bloodborne pathogens.
- b. SCIENTIFIC CONCEPTS THAT FORM THE BASIS FOR THE DEVICE: The Natural rubber Is water tight under normal conditions of use. It's tensile properties cause it to conform to the hand, allowing movements necessary for medical treatment.
- c. PHYSICAL AND PERFORMANCE CHARACTERISTICS SUCH AS DESIGN, MATERIALS AND PHYSICAL PROPERTIES: Natural Rubber Latex is known to create a barrier to bloodborne pathogens and and body fluids. ASTM conforming tensile properties create a glove that is strong and flexible. The glove is manufactured in accordance with the requirements of ASTM D3578-95 and ASTM D5151-92.
1
SUMMARY OF 510(K) SUBMISSION (cont.)
-
- STATEMENT OF INTENDED USE, INCLUDING DESCRIPTION OF THE DISEASES OR CONDITIONS THAT THE DEVICE WILL ADDRESS This is a disposable device, intended for medical purposes, that is worn on the examiner's hand to prevent contamination between patient and examiner. Powder Free gloves are intended for use in situations where powder is not desirable.
6. EXPLANATION OF SIMILARITIES OR DIFFERENCES TO PREDICATE DEVICE · The proposed product is equivalent to gloves currently being marketed in the U.S.
IF SE DECISION BASED ON PERFORMANCE DATA B.
-
- DISCUSSION OF NON-CLINICAL TESTS
| SPECIFICATION | PROPOSED |
|---|---|
| PERFORMANCE | |
| STANDARDS | ASTM D3578-95 |
| WATER TIGHTNESS | ASTM D5151-92 |
-
- DISCUSSION OF CLINICAL TESTS
| SPECIFICATION | PROPOSED |
|---|---|
| SAFETY | |
| RABBIT IRRITATION | Passes |
| GUINEA PIG SENSITIZATION | Passes |
2
SUMMARY OF 510(K) SUBMISSION (cont.)
DISCUSSION OF SAFETY OR EFFECTIVENESS DATA OBTAINED with specific reference to adverse effects and complications
-
- CONCLUSIONS DRAWN FROM NONCLINICAL AND CLINICAL TESTS THAT DEMONSTRATE SAFETY EFFECTIVENESS, AND PERFORMANCE =/> PREDICATE PRODUCT
The Examination Glove has been carefully compared to legally marketed devices in the 510(k). The data summarles indicate that the proposed product meets or exceeds acceptable scores for the predicate product in nonclinical tests, and satisfies the requirements for a safe and effective medical glove.
- CONCLUSIONS DRAWN FROM NONCLINICAL AND CLINICAL TESTS THAT DEMONSTRATE SAFETY EFFECTIVENESS, AND PERFORMANCE =/> PREDICATE PRODUCT
Pursuant to 21 C.F.R. 807.87 ( ) ), I, Edward Markovic, Manager QA/Regulatory Affairs certify that to the best of my knowledge and belief and based upon the data and information submitted to me in the course of my responsibilities as the Manager QA/Regulatory Affairs for Tillotson Healthcare Corporation, and in reliance thereupon, the data and information submitted in this premarket notification are truthful and accurate and that no facts material to a review of the substantial equivalence of this device have been knowingly omitted from this submission.
Edward Muskie
Edward Markovic Manager QA/Regulatory Affairs
3
Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's symbol, which consists of three stylized human profiles facing right, arranged in a stacked formation. The profiles are connected by flowing lines, creating a sense of unity and movement. The symbol is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 1999
Edward Markovic Mr. QA/Requlatory Manager Tillotson Corporation 360 Route 101 Bedford, New Hampshire 03110
Re: K982505 Ultra Care Non-sterile Powder-Free (Green) Trade Name: Natural Rubber Latex Examination Gloves Requlatory Class: I Product Code: LYY Dated: January 4, 1999 Received: February 3, 1999
Dear Mr. Markovic:
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. ਰ 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 In addition, FDA may publish further announcements action. 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
4
Page 2 - Mr. Markovic
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 requlation (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/dsmamain.html".
Sincerely yours,
Piticus Curesitfor
Timothy A. Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
510(K) Submission for Ultra Care Non-Sterile Powder Free (GREEN) Natural Rubber Latex Patient Examination Glove Submission Date: July 20, 1998 510(K) Number:
510(k) Number (if known):
Device Name:
Ultra Care Non-Sterile Powder Free (GREEN) Natural Rubber Latex Patient Examination Glove
Indications For Use:
The Examination Glove is "a disposable device intended for medical purposes that is worn on the examiners hand to prevent contamination between patient and examiner". (21CFR 880.6250)
(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 X
(Optional Format 1-2-96)
Qian S. Lin
(Division Sign-Off) Division of Dental, Infection Control, and General Hospita 510(k) Number