(198 days)
Not Found
No
The summary describes a physical device (surgical gloves) and its performance testing against established standards, with no mention of AI or ML technology.
No
The device is a surgical glove intended to protect a surgical wound from contamination, not to treat or cure a disease or condition.
No
This device, surgical gloves, is intended to protect a surgical wound from contamination and protect the user from chemotherapy drugs. It does not diagnose any condition or disease.
No
The device is a physical glove made of natural rubber, not software. The description focuses on material properties and performance testing related to physical characteristics and chemical resistance.
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 and for use with chemotherapy drugs. This is a protective barrier function for the user and the patient's wound, not a diagnostic test performed on a sample from the body.
- Device Description: The device is a surgical glove made of natural latex rubber. This is a physical barrier device.
- Lack of Diagnostic Activity: There is no mention of the device being used to analyze a sample (blood, urine, tissue, etc.) to provide information about a patient's health status, disease, or condition.
- Testing Performed: The testing described focuses on the physical properties of the glove, its barrier function against chemotherapy drugs, and its biocompatibility. These are performance characteristics of a protective device, not diagnostic performance metrics.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens from the human body to provide information for diagnostic, monitoring, or screening purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
A device made of natural rubber intended to be worn by operating room personnel to protect a surgical wound from contamination. The device has been tested for use with chemotherapy drugs.
Chemotherapy Drug Permeation Chemoticlerapy Drag Formedion time in minutes) (ASTM D6978-05)
| Vincristine Sulfate (1.0mg/mL) | >240 |
|---|---|
| Carmustine (BiCNU)(3.3mg/mL) | 1.5 |
| Cyclophosphamide (Cytoxan)(20.0mg/mL) | >240 |
| Doxorubicin Hydrochloride (2.0mg/mL) | >240 |
| 5-Fluorouracil (50.0mg/mL) | >240 |
| Methotrexate (25.0mg/mL) | >240 |
| Etoposide (Toposar)(20.0mg/mL) | >240 |
| Paclitaxel (Taxol)(6.0mg/mL) | >240 |
| ThioTEPA (10.0mg/mL) | 15.26 |
Please note that Carmustine and ThioTEPA have extremely low permeation times of 1.5 and 15.26 minutes respectively.
Product codes
KGO, LZC
Device Description
The Encore Acclaim Sterile Powder-Free Latex Surgical Gloves, Tested for Use with Chemotherapy Drugs with a Protein Content Label Claim 240
Carmustine (BiCNU)(3.3mg/mL) - 1.5
Cyclophosphamide (Cytoxan)(20.0mg/mL) - >240
Doxorubicin Hydrochloride (2.0mg/mL) - >240
5-Fluorouracil (50.0mg/mL) - >240
Methotrexate (25.0mg/mL) - >240
Etoposide (Toposar)(20.0mg/mL) - >240
Paclitaxel (Toxol)(6.0mg/mL) - >240
ThioTEPA (10.0mg/mL) - 15.26
Carmustine and ThioTEPA have extremely low permeation times.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
KI03714
Ansell
JUL - 7 2011
1635 Industrial Road · Dothan, AL-36303-Tel: (334) 615-2563 Fax: (334) 615-2574
| 510(k) SUMMARY | |
|---|---|
| 1.0 | Submitter: Ansell Healthcare Products LLC |
| 1635 Industrial Road | |
| Dothan, AL 36303 | |
| 2.0 | Contact Information: Cynthia A. Ingram, Regulatory Affairs Manager, Americas |
| Telephone: 334-615-2563 Fax: 334-615-2573 | |
| 3.0 | Name of Device: |
| Trade Name: Encore® Acclaim® Sterile Powder-Free Latex Surgical | |
| Gloves, Tested for Use with Chemotherapy Drugs with a | |
| Protein Content Label Claim 240 | |
| --------------------------------------- | ------- |
| Carmustine (BiCNU)(3.3mg/mL) | 1.5 |
| Cyclophosphamide (Cytoxan)(20.0mg/mL) | >240 |
| Doxorubicin Hydrochloride (2.0mg/mL) | >240 |
| 5-Fluorouracil (50.0mg/mL) | >240 |
| Methotrexate (25.0mg/mL) | >240 |
| Etoposide (Toposar)(20.0mg/mL) | >240 |
| Paclitaxel (Toxol)(6.0mg/mL) | >240 |
| ThioTEPA (10.0mg/mL) | 15.26 |
Please note that Carmustine and ThioTEPA have extremely low permeation times of 1.5 and 15.26 minutes respectively.
- Summary of Technological Characteristics of the Device: 8.0
Encore Acclaim Sterile Powder-Free Latex Surgical Gloves , Tested for Use with Chemotherapy Drugs with a Protein Content Label Claim 50µg/dm² Per Glove of Extractable Protein Regulation Number: 21 CFR 878.4460 Regulation Name: Surgeon's Glove Regulatory Class: I Product Code: KGO. LZC Dated: June 16. 2011 Received: June 17, 2011
Dear Ms. Ingram:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that 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 general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
4
Page 2- Ms. Ingram
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803): good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm l 1 5809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Anthony D, ant
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use Statement: 3.0
INDICATIONS FOR USE
510(k) Number (if known):
Device Name:
Encore Acclaim Sterile Powder-Free Latex Surgical Gloves, Tested for Use with Chemotherapy Drugs with a Protein Content Label Claim 240 |
|---------------------------------------|-------|
| Carmustine (BiCNU)(3.3mg/mL) | 1.5 |
| Cyclophosphamide (Cytoxan)(20.0mg/mL) | >240 |
| Doxorubicin Hydrochloride (2.0mg/mL) | >240 |
| 5-Fluorouracil (50.0mg/mL) | >240 |
| Methotrexate (25.0mg/mL) | >240 |
| Etoposide (Toposar)(20.0mg/mL) | >240 |
| Paclitaxel (Taxol)(6.0mg/mL) | >240 |
| ThioTEPA (10.0mg/mL) | 15.26 |
Please note that Carmustine and ThioTEPA have extremely low permeation times of 1.5 and 15.26 minutes respectively.
AND/OR Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use X (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)
Rophie Rangsukni, PhD.
7/16/2011
ision Sion-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K103714