(76 days)
NEUTRALON* PF* Powder Free Brown 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.
NEUTRALON* PF Powder Free Brown 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 brown in color and are powder free. They are packaged sterile in pairs in size 5-1/2 through size 9.
The provided text describes a 510(k) submission for NEUTRALON* PF POWDER FREE BROWN LATEX SURGICAL GLOVES. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving a new device meets specific, novel acceptance criteria through extensive clinical studies. Therefore, many of the requested details about acceptance criteria, clinical study design, and AI performance will not be applicable or available in this document.
However, I can extract the information that is present:
1. Table of Acceptance Criteria and Reported Device Performance
The device is evaluated against existing standards for rubber surgical gloves. The "acceptance criteria" are implicitly the requirements of these standards.
| Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|
| ASTM D-3577-91 requirements | Product meets the requirements of this standard. |
| 21 CFR 800.20 requirements | Product meets the requirements of this standard. |
| Primary skin irritation (rabbit) | No irritation. |
| Delayed contact sensitization (guinea pig) | No sensitization. |
| Surface extractable particulates (per glove) | Not more than 2 mg. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified in the provided text.
- Data Provenance: Not specified, but generally, testing for compliance with ASTM and CFR standards would be conducted in a laboratory setting. This would be considered non-clinical, controlled testing, not human-patient data from a specific country.
- Retrospective or Prospective: N/A for this type of non-clinical testing.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
N/A. Ground truth for these types of non-clinical, performance-based tests is established by objective measurements against a standard, not by expert consensus on clinical findings.
4. Adjudication Method for the Test Set
N/A. This is not applicable to the non-clinical testing described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No. This is a non-clinical device (surgical glove) and does not involve human readers interpreting images or data, nor does it have an AI component.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No. This is a physical medical device (surgical glove), not an algorithm or AI.
7. The Type of Ground Truth Used
The "ground truth" for the non-clinical tests is the established specifications and limits defined by ASTM D-3577-91 and 21 CFR 800.20 for surgical gloves, as well as the results of standard animal safety tests (skin irritation, sensitization).
8. The Sample Size for the Training Set
N/A. There is no "training set" as this device does not involve machine learning or AI.
9. How the Ground Truth for the Training Set Was Established
N/A. There is no training set for this device.
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510(k) Summary NEUTRALON* PF POWDER FREE BROWN LATEX SURGICAL GLOVES Page 1 of 2
:
| Submitter's Name: | Johnson & Johnson MedicalDivision of Ethicon, 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 11, 1998 |
| Name of Device:Trade Name:Common Name:Classification Name: | NEUTRALON* PF Powder Free Brown Latex SurgicalGlovesSurgical GlovesSurgeon's Gloves |
| Legally Marketed Device to WhichEquivalency is Being Claimed: | NEUTRALON* PF Powder Free Brown Latex SurgicalGloves as described in this 510(k) notification aresubstantially equivalent to the currently marketedULTRALON* Powder Free Latex Surgical Gloves andNEUTRALON* Brown Latex Surgical Gloves. All arelatex gloves with a non-latex polymer inner lining. |
| Description of the Device: | NEUTRALON* PF Powder Free Brown Latex SurgicalGloves meet the description of Rubber Surgical Gloves asdescribed in American Society for Testing Materials(ASTM D 3577-91) as Type 1 gloves compoundedprimarily from natural rubber latex. They are brown incolor and are powder free. They are packaged sterile inpairs in size 5-1/2 through size 9. |
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510(k) Summary NEUTRALON* PF POWDER FREE BROWN LATEX SURGICAL GLOVES Page 2 of 2
| Intended Use of the Device: | NEUTRALON* PF Powder Free Brown Latex SurgicalGloves are intended to protect the wearer from liquidssuch as body fluids and blood, as well as to protectsurgical wounds or sterile fields from microbiologicalcontamination from the wearer. |
|---|---|
| Summary of TechnologicalCharacteristics Compared to thePredicate Device: | The predicate products and the current glove are similarin technology in that they are latex gloves with a non-latexpolymer inner lining. They are dissimilar in pigmentation(NEUTRALON* and NEUTRALON* PF products arebrown in color; the ULTRALON* product is white) and inthe presence of powder (the NEUTRALON* PF andULTRALON products are powder free). |
| 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 contains not more than 2 mg of surfaceextractable particulates/glove. |
| 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 consists of a stylized eagle with three lines forming its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 30 1998
Ms. Margaret L. Marsh Senior Project Manager, Regulatory Affairs Johnson & Johnson Medical Division of Ethicon, Incorporated 2500 Arbrook boulevard 76004-3130 Arlington, Texas
K983240 Re : NEUTRALON* PF Powder Free Brown Latex Trade Name: Surgical Gloves Requlatory Class: I Product Code: KGO September 11, 1998 Dated: Received: September 15, 1998
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 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 Regulations, 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 Requlation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: 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
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Page 2 - Ms. Marsh
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 requlation 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,
K. Mildred
Timothy A. Ulatowski 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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3.0 Indications for Use Statement
Applicant: Johnson & Johnson Medical, Division of Ethicon, Inc.
510(k) Number (if known): K983240
Device Name:
NEUTRALON* PF* Powder Free Brown Latex Surgical Gloves
Indications For Use:
NEUTRALON* PF* Powder Free Brown 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)
Prescription Use: (Per 21 CFR 801.109)
OR Over-the-Counter Use: X
Chris S. Kim
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number
- Trademark
§ 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).