(78 days)
ULTRALON* Powder Free Latex Surgical Gloves are intended to protect the wearer from liquids such as body fluids and blood, as well as to protect surgical wounds or sterile fields from microbiological contamination from the wearer.
ULTRALON* Powder Free Latex Surgical Gloves meet the description of Rubber Surgical Gloves as described in American Society for Testing Materials (ASTM D 3577- 91) as Type 1 gloves compounded primarily from natural rubber latex. They are unpigmented and are powder free. They are packaged sterile in pairs in size 5-1/2 through size 9.
This document is a 510(k) summary for ULTRALON* Powder Free Latex Surgical Gloves, which are surgical gloves, not an AI/ML device. Therefore, the requested information regarding acceptance criteria and studies related to AI/ML device performance (such as sample sizes for test/training sets, expert involvement, MRMC studies, or standalone algorithm performance) is not applicable to this submission.
The acceptance criteria provided here are for traditional medical device testing as per ASTM and FDA regulations for surgical gloves.
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria (Standard) | Reported Device Performance (Compliance) |
|---|---|---|
| Physical Properties | ||
| ASTM D-3577-91 (Rubber Surgical Gloves Standard) | Meets requirements of the standard | Product meets the requirements of the standard |
| 21 CFR 800.20 (Surgical Glove Requirements) | Meets requirements of the standard | Product meets the requirements of the standard |
| Biocompatibility | ||
| Primary Skin Irritation (in rabbit) | No irritation | No irritation |
| Delayed Contact Sensitization (in guinea pig) | No sensitization | No sensitization |
| Excipient-Related Test | ||
| USP Iodine Test (for starch) | Negative for starch | Negative for the presence of starch |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable to this type of medical device which relies on laboratory testing against established standards rather than data sets for performance evaluation. The "test set" here refers to the actual manufactured gloves subjected to various physical and biological tests.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. Ground truth for these physical and biological tests is established by the specifications defined in the ASTM, CFR, and USP standards themselves, which are developed by expert committees and regulatory bodies. The evaluation is against these predefined objective criteria, not through expert consensus on individual "cases."
4. Adjudication Method for the Test Set
Not applicable. Testing involves objective measurements and observations against pre-established pass/fail criteria from recognized standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC study was not done as this is a surgical glove, not an AI/ML diagnostic or assistive device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable, as this is a physical medical device (surgical glove), not an algorithm.
7. The Type of Ground Truth Used
The ground truth is based on:
- Established Industry Standards: ASTM D-3577-91 for Rubber Surgical Gloves.
- Federal Regulations: 21 CFR 800.20 for Surgical Glove Requirements.
- Pharmacopoeia Standards: USP (United States Pharmacopeia) iodine test for starch.
- Biocompatibility Guidelines: Standard animal testing protocols for primary skin irritation and delayed contact sensitization.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/ML device requiring a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as this is not an AI/ML device.
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/ 97 36 99 10 510 510 (k) Summary × 97 36 99
ULTRALON* POWDER FREE LATEX SURGICAL GLOVES Page 1 of 2
| Submitter's Name: | Johnson & Johnson Medical Inc. |
|---|---|
| Submitter's Address: | 2500 Arbrook Blvd.Arlington, Texas 76014 |
| Submitter's Phone Number: | (817) 784-4897 |
| Submitter's Fax Number: | (817) 784-5369 |
| Name of Contact Person: | Margaret Marsh |
| Date of Preparation: | September 26, 1997 |
| Name of Device:Trade Name:Common Name:Classification Name: | ULTRALON* Powder Free Latex Surgical GlovesSurgical GlovesSurgeon's Gloves |
| Legally Marketed Device to WhichEquivalency is Being Claimed: | ULTRALON* Powder Free Latex Surgical Gloves asdescribed in this 510(k) notification are substantiallyequivalent to the currently marketed NEUTRALON*Brown Latex Surgical Gloves. Both are latex gloves withan inner non-latex polymer lining. |
| Description of the Device: | ULTRALON* Powder Free Latex Surgical Gloves meetthe description of Rubber Surgical Gloves as described inAmerican Society for Testing Materials (ASTM D 3577-91) as Type 1 gloves compounded primarily from naturalrubber latex. They are unpigmented and are powder free.They are packaged sterile in pairs in size 5-1/2 throughsize 9. |
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510(k) Summary ULTRALON* POWDER FREE LATEX SURGICAL GLOVES Page 2 of 2
| Intended Use of the Device: | ULTRALON* Powder Free Latex Surgical Gloves areintended to protect the wearer from liquids such as bodyfluids and blood, as well as to protect surgical wounds orsterile fields from microbiological contamination from thewearer. | ||
|---|---|---|---|
| Summary of TechnologicalCharacteristics Compared to thePredicate Device: | The predicate and the current glove are similar intechnology in that they are both latex gloves with an innernon-latex polymer lining. They are dissimilar inpigmentation (the predicate is a brown glove), and in thepresence of powder (the predicate is a powdered glove). | ||
| Brief Discussion of NonclinicalTests: | Testing performed per ASTM D-3577-91 and 21 CFR800.20 indicates that the product meets the requirementsof these standards. | ||
| Primary skin irritation testing in the rabbit and delayedcontact sensitization testing in the guinea pig indicate noirritation or sensitization. | |||
| Final product is negative for the presence of starch usingthe USP iodine test. | |||
| Brief Discussion of Clinical Tests: | No new clinical tests were conducted under this 510(k). | ||
| Conclusions Drawn for theNonclinical and Clinical Tests: | See Nonclinical Test Section above. | ||
| Other Information DeemedNecessary by FDA: | Not applicable |
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the top half of the circle. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 6 1997
Ms. Marqaret L. Marsh Senior Project Manager, Requlatory Affairs Johnson & Johnson Medical, Incorporated 2500 Arbrook Boulevard Arlington, Texas 76004-3130
Re : K973699 Trade Name: ULTRALON™ Powder Free Latex Surgical Glove Requlatory Class: I Product Code: KGO Dated: September 26, 1997 September 29, 1997 Received:
Dear Ms. Marsh:
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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Ms. Marsh
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 requlation 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
Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Johnson & Johnson Medical, Inc. 510(k) Notification ULTRALON* Powder Free Latex Surgical Gloves
3.0 Indications for Use Statement
Applicant: Johnson & Johnson Medical, Inc.
510(k) Number (if known): _K97 3699
Device Name: ULTRALON* Powder Free Latex Surgical Gloves
Indications For Use:
ULTRALON* Powder Free Latex Surgical Gloves are intended to protect the wearer from liquids such as body fluids and blood, as well as to protect surgical wounds or sterile fields from microbiological contamination from the wearer.
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices
| 510(k) Number | K973699 |
|---|---|
| --------------- | --------- |
| Prescription Use: (Per 21 CFR 801.109) | OR | Over-the-Counter Use: ✓ |
|---|---|---|
| ---------------------------------------- | ---- | ------------------------- |
§ 878.4460 Non-powdered surgeon's glove.
(a)
Identification. A non-powdered surgeon's glove is a device intended to be worn on the hands of operating room personnel to protect a surgical wound from contamination. A non-powdered surgeon's 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).