(77 days)
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Not Found
No
The document describes surgical gloves and does not mention any AI or ML technology.
No
Explanation: The device is a surgical glove, intended to protect a surgical wound from contamination, not to treat or diagnose a disease or condition.
No
The device, a surgeon's glove, is intended for protection from contamination, not for diagnosing medical conditions.
No
The device description clearly states it is a physical product (surgical gloves) and does not mention any software components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to protect a surgical wound from contamination by being worn by operating room personnel. This is a barrier function, not a diagnostic function performed on a sample taken from the body.
- Device Description: The description focuses on meeting standards for surgical gloves (ASTM D 3577-99) and being sterile and disposable. This aligns with a medical device used for protection, not for analyzing biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in the body
- Providing information for diagnosis, monitoring, or treatment decisions based on sample analysis.
The device is clearly described as a medical device used for protection during surgery.
N/A
Intended Use / Indications for Use
The Original Perry Style 42 Surgeon's Glove intended use is to be worn by operating room personnel to protect a surgical wound from contamination.
Product codes (comma separated list FDA assigned to the subject device)
KGO
Device Description
The Original Perry Style 42 Powdered Surgeon's Gloves (Protein Label Claim) meet all of the requirements of ASTM D 3577-99, Type 1.
The Original Perry Style 42 Powdered Surgeon's Gloves (Protein Label Claim) meet all the current specifications for ASTM D 3577-99 Rubber Surgical Gloves.
The Original Perry Style 42 Powdered Surgeon's Gloves (Protein Label Claim) are sterile disposable devices intended to be worn by operating room personnel to protect a surgical wound from contamination.
The Original Perry Style 42 Powdered Surgeon's Gloves (Protein Label Claim) are summarized with the following technological characteristics compared to ASTM or equivalent standards.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
operating room personnel
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The performance test data of the non clinical tests are the same as mentioned immediately above.
Clinical data is not needed for medical gloves or for most devices cleared by the 510(k) process.
It is concluded that The Original Perry Style 42 Powdered Surgeon's Gloves (Protein Label Claim) are as safe, as effective, and perform as well as the glove performance standards referenced above and therefore meet: ASTM listed standards, FDA hole requirements, and labeling claims for the product.
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.
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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.
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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
§ 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).
0
Jan 3 1 2000
. .
Attachment 4
510(k) Summary
Summary
Attached
Signature
James R. Chatterton
Typed Name
November 12, 1999
Date
1
K99 3857
The Original Perry Style 42 Powdered Surgeon's Gloves (Protein Label Claim) Ansell Perry 1875 Harsh Avenue SE Massillon, Ohio 44646 Telephone: 330-833-2811 330-833-6213 Fax:
- [1] Summary
- [2] Ansell Perry Inc. 1875 Harsh Avenue SE Massillon, Ohio 44646
| Contact: | James R. Chatterton |
|---|---|
| Telephone: | 330-833-2811 |
| Fax: | 330-833-6213 |
November 12, 1999
- [3] Trade Name: The Original Perry Style 42 Powdered Surgeon's Gloves (Protein Label Claim) Common Name: Surgical Gloves Classification Name: Surgeon's Glove
- [4] The Original Perry Style 42 Powdered Surgeon's Gloves (Protein Label Claim) meet all of the requirements of ASTM D 3577-99, Type 1.
- [5] The Original Perry Style 42 Powdered Surgeon's Gloves (Protein Label Claim) meet all the current specifications for ASTM D 3577-99 Rubber Surgical Gloves.
- The Original Perry Style 42 Powdered Surgeon's Gloves (Protein Label Claim) are sterile disposable [e] devices intended to be worn by operating room personnel to protect a surgical wound from contamination.
- The Original Perry Style 42 Powdered Surgeon's Gloves (Protein Label Claim) are summarized with [7] the following technological characteristics compared to ASTM or equivalent standards.
| Characteristics | Standard |
|---|---|
| Dimensions | Meets ASTM D 3577-99 |
| Physical Properties | Meets ASTM D 3577-99, Type 1 |
| Freedom from holes | Meets ASTM D 3577-99 |
| Meets ASTM D 5151-92 | |
| Protein Label Claim | This latex glove contains 60 micrograms or |
| less of total water extractable protein per | |
| gram. | |
| Meets ASTM D 5712-95 Standard Test | |
| Method for Analysis of Protein in Natural | |
| Rubber and Its Products | |
| Biocompatability |
Primary Skin Irritation in Rabbits Guinea Pig Sensitization
Passes Passes
2
Image /page/2/Picture/0 description: The image shows a handwritten string of characters. The string appears to be "KG93857". The characters are written in a dark ink on a white background. The handwriting is somewhat stylized, with some characters having unique shapes.
The Original Perry Style 42 Powdered Surgeon's Gloves (Protein Label Claim) Ansell Perry 1875 Harsh Avenue SE Massillon, Ohio 44646 Telephone: 330-833-2811 330-833-6213 Fax:
- The performance test data of the non clinical tests are the same as mentioned immediately above. [8]
- Clinical data is not needed for medical gloves or for most devices cleared by the 510(k) process. വി
- It is concluded that The Original Perry Style 42 Powdered Surgeon's Gloves (Protein Label Claim) [10] are as safe, as effective, and perform as well as the glove performance standards referenced above and therefore meet:
ASTM listed standards, FDA hole requirements, and labeling claims for the product.
- [11] This summary will include any other information reasonably deemed necessary by the FDA.
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 a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, with three stylized human profiles incorporated into the design.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 31 2000
Mr. James R. Chatterton Vice President Regulatory Ansell Perry Ansell Healthcare Products, Incorporated 1875 Harsh Avenue S.E. Massillon, Ohio 44646
Re : K993857 Trade Name: The Original Perry, Style 42 White Latex Powdered Surqical Gloves With Protein Content Labeling Claim (60 micrograms or less) Regulatory Class: I Product Code: KGO Dated: November 12, 1999 November 15, 1999 Received:
Dear Mr. Chatterton:
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 reqistration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst 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 requlation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in
4
Page 2 - Mr. Chatterton
the Federal Register. Please note: this response to your premarket notification submission does not affect any premarker nocurright have under sections 531 through 542 of obligation you magne the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as fire ited in your 510 k) premarket notification. The FDA debtired in form of substantial equivalence of your device to a legally marketed predicate device results in a classification for your marketed production permits your device to proceed to the market.
If you desire specific advice for your device on our labeling II you debire bpoort 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be Information on Journal Manufacturers Assistance obeation 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
Diredtor Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Attachment 2
Indications for Use Statement
| 510(k) Number (if known) | K993857
None, preamendments device |
|--------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | The Original Perry Style 42
White latex powdered surgical gloves with Protein Content Labeling Claim
(60 micrograms or Less) |
| Indications for Use | The Original Perry Style 42 Surgeon's Glove intended use is to be worn by
operating room personnel to protect a surgical wound from contamination. |
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
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出している。
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Over-The-Counter Use $\longrightarrow$
Qiu S. Lin
(Division Sign-Off) Division of Dental, Infectio and General Hospita 510(k) Number _
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