(222 days)
Not Found
No
The summary describes a standard medical glove and does not mention any AI or ML components or functionalities.
No
The device is a medical glove intended for protection against contamination and chemotherapeutic agents, not for treating a disease or condition.
No
Explanation: The device is a medical glove, which is used for protection and contamination prevention, not for diagnosing a disease or condition.
No
The device is a physical glove, not software. The description clearly outlines its material, thickness, and physical characteristics.
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 patients and to protect the wearer from chemotherapeutic agents. This is a barrier function, not a diagnostic function performed in vitro (outside the body).
- Device Description: The description is of a physical glove, not a reagent, instrument, or system used to examine specimens from the human body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting substances, or providing diagnostic information about a patient's health status.
- Performance Studies: The performance studies listed relate to the physical properties and barrier function of the glove (strength, chemical resistance, irritation), not diagnostic accuracy or analytical performance.
IVDs are used to examine specimens from the human body (like blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This glove does not perform any such function.
N/A
Intended Use / Indications for Use
A medical glove worn on the hand of a healthcare worker and similar personnel to prevent contamination between healthcare personnel and patient. In addition, this glove is worn for the protection of the wearer against exposure to chemotherapeutic agents.
Product codes (comma separated list FDA assigned to the subject device)
LZC
Device Description
8 mil thick, Non Sterile, fitted or ambidextrous, Nitrile gloves with beaded cuff extending beyond the wrist.
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
healthcare worker and similar personnel
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)
The Sage nitrile glove have been tested per the following standards
- 21 CFR 800.20 .
- . ASTM D412
- ASTM 1342-91 .
- ASTM 739-91 .
- NFPA 1999 .
- Blue Book Memorandum #G95-1, Sensitization, and Primary Irritation Testing .
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.
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
AUG 25 1997
Image /page/0/Picture/2 description: The image shows a sequence of handwritten alphanumeric characters. The characters are 'K970135'. The characters are written in a simple, slightly irregular style, with varying stroke thicknesses.
510(k) Summary for Sage Nitrile 14
This summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 90.
| Submitter Name | Karen Pinto, Regulatory Affairs Manager |
|---|---|
| Company Name | Sage Products Inc. |
| Street Address | 815 Tek Drive, Crystal Lake, IL 60014 |
| Contact Person | Karen Pinto, Regulatory Affairs Manager |
| Telephone of Contact Person | 815-455-4700 ext. 1383 |
| Fax of Contact Person | 815-455-5599 |
| Date of Summary Preparation | May 8, 1997 |
| Device Name | |
| Trade or Proprietary Name | Nitrile Gloves (POWDER FREE, EXAMINATION GLOVE) |
| Classification Name | Patient Examination Gloves (CFR: 800.6250) |
| Common Name | Exam Gloves |
| Indications for Use | A medical glove worn on the hand of a healthcare worker and |
| similar personnel to prevent contamination between healthcare | |
| personnel and patient. In addition, this glove is worn for the | |
| protection of the wearer against exposure to chemotherapeutic | |
| agents. | |
| Description: | 8 mil thick, Non Sterile, fitted or ambidextrous, Nitrile gloves with |
| beaded cuff extending beyond the wrist. |
Page 13 of 16
Response to 8/19/1997 Request for Revisions
"Innovative health care products since 1971"
1
Image /page/1/Picture/2 description: The image shows the logo for SAGE PRODUCTS INC. The logo is in black and white and features a bold, sans-serif font. The word "SAGE" is in large letters, and the words "PRODUCTS INC" are in smaller letters below. There is a line above the word "PRODUCTS" and below the word "INC".
510(k) Summary for Sage Nitrile Gloves, K970135 (Continued) 14
Substantial Equivalence Comparison
| Product
Name | Nitrile
Gloves | Safeskin | Nitrex | N-Dex | N-Dex | N-Dex |
|----------------------------------|------------------------------------------------------|------------------------------------------------------|---------------------------------------------------------------|-------------------------------------------------------|----------------------------------------------------------------------------|----------------------------------------------------------------------------|
| Manufac-
turer | Sage
Products, Inc. | Safeskin | Delta Hospital
Supply, Inc. or
Delta Medical
Systems | Best | Best | Best |
| Product Code | Undetermined | N-110 | UNT-100 | 8005 | 9005 | 9905 |
| K Number | Has not been
assigned yet | Could not
locate | Could not
locate | Could not
locate | K902696 | K915086 |
| Address | Crystal Lake,
IL | San Diego,
CA | Norwood,
Mass or
Duluth, GA | Menlo, GA | Menlo, GA | Menlo, GA |
| Intended Use
of Product | Patient
examination
and personal
protection | Patient
examination
and personal
protection | Patient
examination
and personal
protection | Personal
protection,
Food and
Pharmaceutical | Patient examination,
personal protection,
Food and
Pharmaceutical | Patient examination,
personal protection,
Food and
Pharmaceutical |
| Sizes available | xs, s, m, l , xl | xs, s, m, l,
xl | s, m, l, xl | s, m, l, xl | s, m, l , xl | s, m, l , xl |
| Material | Nitrile | Nitrile | Nitrile | Nitrile | Nitrile | Nitrile |
| Orientation | Fitted and
Ambidextrous | Ambidex-
trous | Ambidextrous | Ambidextrous | Fitted | Ambidextrous |
| Cuff | Beaded | Beaded | Beaded | Beaded | Beaded | Beaded |
| Color | White | Blue | Blue | Blue | Blue | Blue |
| Product Code | Undetermined | N-110 | UNT-100 | 8005 | 9005 | 9905 |
| Sterility | Non-Sterile | Non-Sterile | Non-Sterile | Non-Sterile | Non-Sterile | Non-Sterile |
| Length (in.) | 12 | 9 1/2 | 11 | 9 1/2 | 11 | 11 |
| Fingertip
Thickness
(mil) | 8 | 6 | 6 | 8 | 6 | 6 |
| Presence of
Donning
Powder | No | No | No | Yes | Available with and
without | Available with and
without |
Page 14 of 16
Response to 8/19/1997 Request for Revisions
"Innovative health care products since 1971"
2
Image /page/2/Picture/2 description: The image shows the logo for SAGE PRODUCTS INC. The logo is in black and white and features the word "SAGE" in large, bold letters. Below the word "SAGE" is the phrase "PRODUCTS INC" in smaller letters. A horizontal line is placed above the phrase "PRODUCTS INC".
510(k) Summary for Sage Nitrile Gloves, K970135 (Continued) 14
Performance Test Summary
The Sage nitrile glove have been tested per the following standards
- 21 CFR 800.20 .
- . ASTM D412
- ASTM 1342-91 .
- ASTM 739-91 .
- NFPA 1999 .
- Blue Book Memorandum #G95-1, Sensitization, and Primary Irritation Testing .
Page 15 of 16
Response to 8/19/1997 Request for Revisions
"Innovative health care products since 1971"
3
Image /page/3/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services USA. The logo features a stylized abstract symbol resembling an eagle or a person with outstretched arms. The symbol is positioned to the right of the text, which is arranged in a circular pattern around the symbol. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA".
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Karen Pinto Requlatory Affairs Manager Sage Products Incorporated 815 Tek Drive P.O. Box 9693 60014-9693 Crystal Lake, Illinois
AUG 25 1997
Re : K970135 Saqe Powder-Free Nitrile Examination Gloves Trade Name: Regulatory Class: I Product Code: LZC Dated: May 23, 1997 Received: June 3, 1997
Dear Ms. Pinto:
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, 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. A 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 Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531
4
Page 2 - Ms. Pinto
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 diaqnostic 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" (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.fdaygov/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
101 ﺴﻮ Page
| 510(k) Number (if known): | K970135 |
|---|---|
| Device Name: | Sage Nitrile Gloves (POWDER FREE EXAMINATION GLOVE) |
Indications For Use:
A medical glove worn on the hand of a healthcare worker and similar personnel to prevent contamination between healthcare personnel and patient. In addition, this glove is worn for the protection of the wearer against exposure to chemotherapeutic agents.
[Secrion 15, page 16 of 16, Pre-Market Notification: Nitrile Gloves]
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Chis S. Lin
(Division Sign-Off)
Division of Dental, Infection Control, and General Hospital Devices 510(k) Number
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use X
(Optional Formal 1-2-96)