(47 days)
Not Found
Not Found
No
The summary describes surgical gloves and does not mention any AI or ML capabilities.
No
The text describes the gloves as being worn by operating room personnel to protect a surgical wound from contamination, which is a preventative measure, not a therapeutic one.
No
The device, Encore Sterile Powder-Free Polymer Coated Latex Surgical Gloves, is intended to protect a surgical wound from contamination, not to diagnose a disease or condition.
No
The device is described as physical gloves, which are hardware, not software.
Based on the provided information, 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 test performed on samples taken from the body.
- Device Description: The description reinforces the intended use as a protective barrier.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting specific substances, or providing diagnostic information about a patient's health status.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition. This device does not fit that description.
N/A
Intended Use / Indications for Use
These gloves are intended to be worn by operating room personnel to protect a surgical wound from contamination. These latex gloves contain 50 micrograms or less of water extractable protein per gram.
Product codes (comma separated list FDA assigned to the subject device)
KGO
Device Description
Encore Sterile Powder-Free Polymer Coated Latex Surgical Glove With Hydrasoft Coating (containing Glycerine) And Protein Labeling Claim (50 micrograms or less) are sterile disposable devices intended to be worn by operating room personnel to protect a surgical wound from contamination. These latex gloves contain 50 micrograms or less of water extractable protein per gram.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
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
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 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 Encore Sterile Powder-Free Polymer Coated Latex Surgical Glove With Hydrasoft Coating (containing Glycerine) And Protein Labeling Claim (50 micrograms or less) are as safe, as effective, and perform as well as the glove performance standards referenced in Section 7 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.
Not Found
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
§ 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
AUG 1 7 2005
051793
Page 1 of 2
510(k) SUMMARY [1]
- Ansell Healthcare Products LLC [2] 1635 Industrial Road Dothan, AL 36303
Lon D. McIlvain, Vice President Regulatory Affairs Contact: (334) 615-2562 Telephone: (334) 615-2568 Fax:
June 29, 2005
| [3] Trade Name: | Encore Sterile Powder-Free Polymer Coated Latex Surgical Glove With Hydrasoft Coating (containing Glycerine) And Protein Labeling Claim (50 micrograms or less) |
|---|---|
| ----------------- | ----------------------------------------------------------------------------------------------------------------------------------------------------------------- |
Surgical Gloves Common Name:
Classification Name: Surgeon's Glove
- Encore Sterile Powder-Free Polymer Coated Latex Surgical Glove With Hydrasoft (4) Encore Sterne Forwards And Protein Labeling Claim (50 micrograms or less) Couting (Containents of ASTM D 3577, Type 2.
- Encore Sterile Powder-Free Polymer Coated Latex Surgical Glove With Hydrasoft ાં રો Enoore Sterne in the Glycerine) And Protein Labeling Claim (50 micrograms or less) Southing (Sthe current specifications of ASTM D 3577, Type 2.
- Encore Sterile Powder-Free Polymer Coated Latex Surgical Glove With Hydrasoft (୧) Eneore Sterne ining Glycerine) And Protein Labeling Claim (50 micrograms or less) are sterile disposable devices intended to be worn by operating room personnel to protect a surgical wound from contamination. These latex gloves contain 50 micrograms or less of water extractable protein per gram.
- Encore Sterile Powder-Free Polymer Coated Latex Surgical Glove With Hydrasoft [7] Coating (containing Glycerine) And Protein Labeling Claim (50 micrograms or less) arc summarized with the following technological characteristics compared to ASTM or equivalent standards.
| Characteristics | Standard |
|---|---|
| Dimensions | Meets ASTM D 3577 |
| Physical Properties | Meets ASTM D 3577, Type 2 |
| Freedom from Holes | Meets ASTM D 3577 |
| Meets ASTM D 5151 | |
| Powder-Free | Meets ASTM D 6124 |
| Powder content ≤ 2 mg per glove |
1
Biocompatibility:
FHSA Skin Irritation Study ISO Maximization Sensitization Study Cytotoxicity Study using the End-Point Titration Method
K051793
page2of2
Non-Toxic at 24 hours
Passes
Passes
Encore Sterile Powder-Free Polymer Coated Latex Surgical Glove With Hydrasoft Encore Sterne Fowder Trowder Trotein Labeling Claim (50 micrograms or less) have the additional characteristic:
| Protein Label Claim: This latex glove |
|---|
| contains 50 micrograms or less of |
| total water extractable protein per |
| gram |
Meets ASTM D 5712-99 Standard Test Method for Analysis of Protein in Natural Rubber and Its Products
- The performance test data of the non-clinical tests are the same as mentioned [8] immediately above.
- Clinical data is not needed for medical gloves or for most devices cleared by the ીતે તે જે તે તે જ દૂધની ડેરી જેવી સવલતો પ્રાપ્ય થયેલી છે. આ ગામનાં લોકોનો મુખ્ય વ્યવસાય ખેતી, ખેતમજૂરી તેમ જ પશુપા 510(k) process.
- It is concluded that Encore Sterile Powder-Free Polymer Coated Latex Surgical Glove [10] With Hydrasoft Coating (containing Glycerine) And Protein Labeling Claim (50 micrograms or less) are as safe, as effective, and perform as well as the glove performance standards referenced in Section 7 above and therefore meet:
ASTM listed standards, FDA hole requirements, and labeling claims for the product.
- This summary will include any other information reasonably deemed necessary by the [11] FDA.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized depiction of an eagle or bird with three curved lines representing its wings or feathers. The bird is positioned within a circular border. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is written around the border of the circle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 17 2005
Ansell Healthcare Products, LLC C/O Ms. Cynthia A. Ingram Regulatory Affairs Manager, Americas 1635 Industrial Road Dothan, Alabama 36303
Re: K051793
Trade/Device Name: Encore Sterile Powder-Free Polymer Coated Latex Surgical Glove with Hydrasoft coating (containing Glycerine) and Protein Labeling Claim (50 micrograms or less) Regulation Number: 21 CFR 878.4460 Regulation Name: Surgeon's glove Regulatory Class: I Product Code: KGO Dated: June 30, 2005 Received: July 1, 2005
Dear Ms. Ingram:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your betermined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for ass stated in the energe, 1976, the enactment date of the Medical Device Amendments, or to conniner or prior to ria) 20, since) in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act (Act (Act do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou mayy areres, while 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
3
Page 2 - Ms. Ingram
Please be advised that FDA's issuance of a substantial equivalence determination does not mean r lease be advised that i Dr mination that your device complies with other requirements of the Act that I Dri Hab made a and regulations administered by other Federal agencies. You must or uny I vith all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CI K rut 6077, aboning (21 (QS) regulation (21 CFR Part 820); and if applicable, the electronic rordly in and quians of trol provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation of the provide as are in arketing your device as described in your Section 510(k) I mis lotter will and my Jorne FDA finding of substantial equivalence of your device to a legally prematicated predicated." - 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), please If you active of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general international and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Ching Liu, Ph.D.
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement: 3.0
INDICATIONS FOR USE
510(K) Number (if known): K051793
Device Name:
Encore Sterile Powder-Free Polymer Coated Latex Surgical Glove with Hydrasoft coating (containing Glycerine) and Protein Labeling Claim (50 micrograms or less)
Indications For Use:
These gloves are intended to be worn by operating room personnel to protect a surgical wound from contamination. These latex gloves contain 50 micrograms or less of water extractable protein per gram.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH Office of Device Evaluation (ODE)
Shelli A. Murphy, ko 8/16/05
(Division Sign-C Division of Anesthesi Intection Control, Dental
510(k) Number. K051243 -12-