(71 days)
KI
Not Found
No
The device is a medical examination glove, and the description focuses on material properties and performance standards, with no mention of AI or ML.
No
The device, an examination glove, is intended to prevent contamination between patient and examiner, acting as a barrier rather than directly treating or diagnosing a medical condition.
No
The device is described as an examination glove intended to prevent contamination between the patient and examiner, not to diagnose medical conditions.
No
The device description clearly states it is a physical glove made of Natural Rubber Latex, intended to be worn on the hand. It describes material properties and manufacturing standards for a physical product, not software.
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 examiner's hand to prevent contamination between patient and examiner." This describes a barrier device used for protection during medical examinations.
- Device Description: The description focuses on the physical properties of the glove (material, strength, barrier properties) and its manufacturing standards.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This glove does not perform any such analysis or provide diagnostic information.
The information provided aligns with the description of a Class I medical device (examination glove) used for barrier protection, not an IVD.
N/A
Intended Use / Indications for Use
The Powder Free, 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.". (21CFR 880.6250).
Product codes
LYY
Device Description
Natural Rubber Latex films form an excellent barrier to body fluids and bloodborne pathogens. The latex rubber is water tight under normal concreases of ovements necessary for medical treatment. Natural Rubber Latex is known to create a superior barrier to bloodborne pathogens and and body fluids. ASTM conforming tensile properties create a glove that is strong and flexible. The leaching process removes traces of chemical accelerants that may be chemically irritating. The glove is manufactured in accordance with the requirements of ASTM D3578 and ASTM D5151 requirements.
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
Non-clinical tests were performed based on specifications for Powder Free (low protein) gloves. Performance standards were evaluated using ASTM D3578, water tightness with ASTM D5151, and protein content with ASTM D5712. Clinical tests for safety, specifically rabbit irritation, showed the device "Passes".
Key Metrics
Not Found
Predicate Device(s)
Powder Free, Hype 1 1 4 1 Examination Glove KI (with low protein claim)
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
K974065
JAN. 4, 1998
SUMMARY OF 510(k) Submission # K97
- INFORMATION A.
-
- 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
360 Route 101
- PREDICATE DEVICE IDENTIFICATION NAME, NUMBER
TILLOTSON HEALTHCARE CORPORATION
Bedford, NH 03110 U.S.A.
(603) 472-6600
Edward Markovic
October 17, 1997
Powder Free, Examination Glove
Examination Glove
Examination Glove
- Powder Free, Hype 1 1 4 1
Examination Glove KI (with low protein claim)
(which low protein grain)
-
- DESCRIPTION OF DEVICE
- DESCRIF TION DEVICE FUNCTIONS: HOW THE DEVICE FUNCTIONS:
Natural Rubber Latex films form an excellent barrier to body fluids and bloodborne pathogens. - b. SCIENTIFIC CONCEPTS THAT FORM THE BASIS FOR THE DEVICE:
- SCIENTIFIC CONCEPTS THAT FORM THE BADIC HONDANIA of use. It's tensile The latex rubber is water tight under normal concreases of ovements necessary for medical treatment.
PHYSICAL AND PERFORMANCE CHARACTERISTICS SUCH AS DESIGN, MATERIALS
| C. PHYSICAL AND PERFORMANCE |
|---|
| AND PHYSICAL PROPERTIES: |
| Natural Rubber Latex is known to create a superior barrier to bloodborne pathogens and |
| and body fluids. ASTM conforming tensile properties create a glove that is strong |
| and flexible. The leaching process removes traces of chemical accelerants that |
| may be chemically irritating. The glove is manufactured in accordance with the |
| requirements of ASTM D3578 and ASTM D5151 requirements. |
1
SUMMARY OF SAFETY AND EFFECTIVENESS (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. |
|---|
| Low protein claim surgical gloves are suitable in situations |
| where healthcare worker or patient allergic sensitivity may be a factor. Powder free |
| gloves are intended for use in situations where powder is not desirable. |
-
- EXPLANATION OF SIMILARITIES OR DIFFERENCES TO PREDICATE DEVICE
| . The proposed product is identical to the predicate product and is
| The first of the country of the consisted on the consisted on the comments of the comments of the comments of the comments of the comments of the comments of the comments of |
|---|
| sultable for situations where a low sensitizing glove is desirable. |
- · It is powder free, (with low protein claim) in the same way as predicate product.
B. IF SE DECISION BASED ON PERFORMANCE DATA
-
- DISCUSSION OF NON-CLINICAL TESTS
| SPECIFICATION | PROPOSED | PREDICATE |
|---|---|---|
| Powder Free | ||
| (low protein) | Powder Free | |
| Hypoallergenic | ||
| (low protein) | ||
| PERFORMANCE | ||
| STANDARDS | ASTM D3578 | ASTM D3578 |
| WATER TIGHTNESS | ASTM D5151 | ASTM D5151 |
| PROTEIN | ASTM D5712 | ASTM D5712 |
| DISCUSSION OF CLINICAL TESTS | ||
| SPECIFICATION | ||
| SAFETY | ||
| RABBIT IRRITATION | Passes | Passes |
2
SUMMARY OF SAFETY AND EFFECTIVENESS (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 CONCEGSIONS DRAWN PROM PERFORMANCE =/> PREDICATE PRODUCT
The Powder Free, Hypoallergenic Examination Glove has been carefuly compared The Powder Free, I rypocas in the 510(k). The data summaries indicate that the propolsed w again managed acceptable scores for the prodicate product in nonclinical tests, and satisfies the requirements for a safe and effective powder free, hypoallergenic medical glove.
- CONCLUSIONS DRAWN FROM NONCLINICAL AND CLINICAL TESTS THAT DEMONSTRATE CONCEGSIONS DRAWN PROM 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 Markovic Manager QA/Regulatory Affairs
3
Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like symbol with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN - 6 1998
Mr. Edward Markovic Manager Quality Assurance/Regulatory Affairs Tillotson Healthcare Corporation 360 Route 101 03110 Bedford, New Hampshire
K974065 Re : Powder Free Latex Examination Glove (with Trade Name: Protein Claim) 50 micrograms or less of total water extractable protein per gram Regulatory Class: I Product Code: LYY Dated: October 17, 1997 Received: October 27, 1997
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 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, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, qood 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. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (QS) for Medical General requlation (21 CFR Part 820) and that, Devices: through periodic (OS) 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
4
Page 2 - Mr. Markovic
not affect any obligation you might have under sections 531 not arrece any obangat for devices under the Electronic ciffough 542 or cho notrol 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 described in your tial equivalence of your device to a legally marketed predicate device results in a classification for your marketed predicate anits 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) 594-4618. 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" (21 CFR 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/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
5
510(k) Number (if known):
Page 1 of 1
Device Name:
on Glove beling claim) h com ins 60 microarams or loss This glove com of total water extractable protein per gram.
510/k) 974065
Indications For Use:
The Powder Free, 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.". (21CFR 880.6250).
(PLEASE DO NOT WRITE BELOW THIS LINE
CONTINUE ON ANOTHER PAGE IF NEEDED)
| (Division Sign-Off) | Concurrence of CDRH, Office of Device Evaluation (ODE) | ||
|---|---|---|---|
| Division of Dental, Infection Control, | |||
| and General Hospital Devices | |||
| 510(k) Number | V974065 | ||
| Prescription Use | Over-The-Counter Use | X |
(Per 21 CFR 801.109)
.................
ﺗ
ﻪ ﺳ
Over-The-Counter Use X
(Optional Format 1-2-98)
REVISED Section B (2) INDICATIONS FOR USE NSO9001\REGUL\510KVK974086\KCLOR.XLS
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