(80 days)
Not Found
No
The 510(k) summary describes a standard examination glove and its testing for chemotherapy drug permeation. There is no mention of AI, ML, image processing, or any other technology that would suggest the use of AI/ML.
No
Explanation: This device is an examination glove, which is a barrier device used for protection and contamination prevention, not for treating a disease or condition.
No
Explanation: The device description states it is an examination glove intended to prevent contamination. Its performance studies focus on physical properties, biocompatibility, and chemotherapy drug permeation, not on diagnosing medical conditions.
No
The device is a physical examination glove, which is a hardware medical device, not a software-only device. The description focuses on physical properties and performance studies related to material and drug permeation.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is a "disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner." This describes a barrier device used externally.
- IVD Definition: In vitro diagnostics (IVDs) are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. This device does not perform any such testing on biological samples.
- Device Description: The description focuses on the physical characteristics and testing related to its barrier function and resistance to chemotherapy drugs.
- Lack of IVD-related information: There is no mention of analyzing biological samples, detecting biomarkers, or any other activity typically associated with IVDs.
The testing for chemotherapy drug permeation is related to the device's performance as a protective barrier, not as a diagnostic tool.
N/A
Intended Use / Indications for Use
The examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation of Chemotherapy Drugs:
| Chemotherapy Drug and Concentration | Minimum Breakthrough Detection Time in Minutes |
|---|---|
| Carmustine (BCNU)(3.3 mg/mL) | 15.4 |
| Cisplatin (1.0 mg/mL) | >240 |
| Cyclophosphamide (Cytoxan) (20.0 mg/mL) | >240 |
| Dacarbazine (DTIC) (10.0 mg/mL) | >240 |
| Doxorubicin Hydrochloride (2.0 mg/mL) | >240 |
| Etoposide (20.0 mg/mL) | >240 |
| Fluorouracil (Adrucil) (50.0 mg/mL) | >240 |
| Methotrexate (25 mg/mL) | >240 |
| Mitomycin C (0.5mg/mL) | >240 |
| Paclitaxel (taxol) (6.0 mg/mL) | >240 |
| Thiotepa (10.0 mg/mL) | 1.6 |
| Vincristine Sulfate (1.0 mg/mL) | >240 |
The maximum testing time is 240 minutes. Please note that the following drugs, Carmustine (BCNU) and Thiotepa have extremely low permeation time of less than 30 minutes.
Product codes
LZC
Device Description
Textured, Blue, Latex Powder Free Examination Gloves, Tested For Use With Chemotherapy Drugs With Protein Labeling Claim (50µg/dm² Or Less Of Water Soluble Protein).
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
Not Found
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
Nonclinical data assessment performed based on standards ASTM Standard D3578-05 for Dimension and Physical Properties, 21 CFR 800.20; ASTM D5151-06 for Freedom from Pinholes, ASTM Standard D6124-06 for Powder Residual, ASTM Standard D5712-10 for Protein Level, and Biological Evaluation of Medical Devices part 1: Evaluation and Testing (ISO 10993-1:2009) and Primary Skin Irritation in rabbits (ISO 10993-10:2010) and Dermal Sensitization in the guinea pig (ISO 10993-10:2010) for Biocompatibility. All characteristics were found to meet the standards; gloves are non-irritating and do not display any potential for sensitization.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 880.6250 Non-powdered patient examination glove.
(a)
Identification. A non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. A non-powdered patient examination 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). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.
0
Abbreviated 510(k) Premarket Notification Latex Powder Free Examination Gloves
510(k) SUMMARY
Section 5, 510(k) Summary Page 1 of 3
? �。
K121926/.
| DATE: | February 17, 2010 | SEP 2 0 2012 | |
|---|---|---|---|
| OWNER: | McKesson Medical Surgical International | ||
| 70 Sir John Rogerson's Quay | |||
| Dublin 2, Ireland | |||
| OFFICIAL CORRESPONDENT: | Anthony L. Giaccio | ||
| Manager, Quality Systems and Regulatory Affairs | |||
| Telephone: 815-385-0100 | |||
| Fax: 815-385-0114 | |||
| Email: Anthony.Giaccio@mckesson.com | |||
| DEVICE NAME: | Trade Name: | Textured, Blue, Latex Powder Free Examination | |
| Gloves, Tested For Use With Chemotherapy | |||
| Drugs With Protein Labeling Claim (50μg/dm2 | |||
| Or Less Of Water Soluble Protein) | |||
| Common Name: | Patient Examination Gloves | ||
| Classification: | Patient Examination Gloves | ||
| Class: | Class I | ||
| Product Code: | LZC |
PREDICATE DEVICE(S):
| Predicate
510(k) | Device Name | Indication | Clearance
Date | Company |
|---------------------|------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------|---------------------------------|
| K083409 | Latex Powder Free
Examination Gloves
(Blue) Tested For
Use With
Chemotherapy Drugs | The latex examination glove (Tested for
Use with Chemotherapy Drugs) is a
disposable device intended for medical
and dental purposes that is worn on the
examiner's hand to prevent
contamination between patient and
examiner. | 29 Jul 2009 | WRP ASIA
PACIFIC SDN,
BHD |
DEVICE DESCRIPTION: Textured, Blue, Latex Powder Free Examination Gloves, Tested For Use With Chemotherapy Drugs With Protein Labeling Claim (50µg/dm² Or Less Of Water Soluble Protein).
1
STATEMENT OF INTENDED USE:
The examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
i
In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation of Chemotherapy Drugs:
Chemotherapy Drug Permeation (Breakthrough Detection Time in Minutes)
| Chemotherapy Drug | Average Breakthrough
Detection Time (Min) |
|-------------------------------------------|----------------------------------------------|
| Carmustine (BCNU) (3.3 mg/mL) | 15.4 |
| Cisplatin (1.0 mg/mL) | No breakthrough up to 240 min |
| Cyclophosphamide (Cytoxan)
(20.0 g/mL) | No breakthrough up to 240 min |
| Dacarbazine (DTIC) (10.0
mg/mL) | No breakthrough up to 240 min |
| Doxorubicin Hydrochloride (2.0
mg/mL) | No breakthrough up to 240 min |
| Etoposide (20.0 mg/mL) | No breakthrough up to 240 min |
| Fluorouracil (Adrucil) (50.0
mg/mL) | No breakthrough up to 240 min |
| Methotrexate (25.0 mg/mL) | No breakthrough up to 240 min |
| Mitomycin C (0.5mg/mL) | No breakthrough up to 240 min |
| Paclitaxel (Taxol) (6.0mg/mL) | No breakthrough up to 240 min |
| Thiotepa (10.0 mg/mL) | 1.6 |
| Vincristine Sulfate (1.0 mg/mL) | No breakthrough up to 240 min |
The maximum testing time is 240 minutes. Please note that the following drugs, Carmustine and Thiotepa, have extremely low permeation time of less than 30 minutes.
The Latex Powder Free Examination Glove is substantially equivalent to the predicate device with regard to physical characteristics, design, product features, and intended use. Both gloves are made with latex using similar manufacturing processes. In addition, both gloves have been tested for use with chemotherapy drugs.
TECHNOLOGICAL CHARACTERISTICS:
2
Abbreviated 510(k) Premarket Notification Latex Powder Free Examination Gloves
Section 5, 510(k) Summary Page 3 of 3
:
ASSESSMENT OF NONCLINICAL DATA:
| Characteristic | Standard | Device
Performance |
|--------------------------|--------------------------------------------------------------------------------------------------|----------------------------------------------------------------------|
| Dimension | ASTM Standard D3578-05 | Meets |
| Physical Properties | ASTM Standard D3578-05 | Meets |
| Freedom from
Pinholes | 21 CFR 800.20; ASTM D5151-
06 | Meets |
| Powder Residual | ASTM Standard D6124-06 | Meets
Results generated
values below 2mg of
residual powder |
| Protein Level | ASTM Standard D5712-10 | Meets
Results generated
values below 50
mcg/mg of protein |
| Biocompatibility | Biological Evaluation of Medical
Devices part 1: Evaluation and
Testing (ISO 10993-1:2009) | Meets |
| | Primary Skin Irritation in rabbits
(ISO 10993-10:2010) | Gloves are non-
irritating |
| | Dermal Sensitization in the
guinea pig (ISO 10993-10:2010) | Gloves do not display
any potential for
sensitization |
CONCLUSIONS:
The Latex Powder Free Examination Gloves meet the requirements of established standards ASTM D3578-05, ASTM D5712-10, ASTM D5151-06, ASTM D6124-06 ISO 10993-1:2009 and ISO 10993-10:2010.
Based on the comparison of intended use, design, materials and performance, the Latex Powder Free Examination Gloves Tested for Use With Chemotherapy Drugs are substantially equivalent to the predicate device.
3
Image /page/3/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" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
SEP 20 2012
Northstar Healthcare Holdings C/O Mr. Ned Devine Senior Staff Engineer Underwriters Laboratories. Incorporated 333 Pfingsten Road Northbrook, Illinois 60062
Re: K121926
Trade/Device Name: Textured, Blue, Latex Powder Free Examination Gloves, Tested For Use With Chemotherapy Drugs With Protein Labeling Claim (50 ug/dm2 Or Less Of Water Soluble Protein)
Regulation Number: 21 CFR 880.6250
Regulation Name: Patient Examination Gloves
Regulatory Class: Class I
Product Code: LZC
Dated: September 4, 2012
Received: September 5, 2012
Dear Mr. Devine:
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- Mr. Devine
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/ucm115809.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,
For Scott Robertson
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
510(k) Number (if known): K121926
Device Name: Textured, Blue, Latex Powder Free Examination Gloves, Tested For Use With Chemotherapy Drugs With Protein Labeling Claim (50ug/dm2 Or Less Of Water Soluble Protein).
Indications for Use: The examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation of Chemotherapy Drugs:
| Chemotherapy Drug and Concentration | Minimum Breakthrough Detection Time in
Minutes |
|-----------------------------------------|---------------------------------------------------|
| Carmustine (BCNU)(3.3 mg/mL) | 15.4 |
| Cisplatin (1.0 mg/mL) | >240 |
| Cyclophosphamide (Cytoxan) (20.0 mg/mL) | >240 |
| Dacarbazine (DTIC) (10.0 mg/mL) | >240 |
| Doxorubicin Hydrochloride (2.0 mg/mL) | >240 |
| Etoposide (20.0 mg/mL) | >240 |
| Fluorouracil (Adrucil) (50.0 mg/mL) | >240 |
| Methotrexate (25 mg/mL) | >240 |
| Mitomycin C (0.5mg/mL) | >240 |
| Paclitaxel (taxol) (6.0 mg/mL) | >240 |
| Thiotepa (10.0 mg/mL) | 1.6 |
| Vincristine Sulfate (1.0 mg/mL) | >240 |
The maximum testing time is 240 minutes. Please note that the following drugs, Carmustine (BCNU) and Thiotepa have extremely low permeation time of less than 30 minutes.
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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
ion of Anestheslology, General Hospital Infection Control, Dental Devices
510(k) Number;