(49 days)
Not Found
No
The device is a standard examination glove and the summary contains no mention of AI or ML technology.
No
The device is described as an examination glove intended to prevent contamination between patient and examiner, which is a prophylactic measure, not a therapeutic one. It does not treat or cure a disease or condition.
No
Explanation: The device is an examination glove, intended to prevent contamination between patient and examiner, not to diagnose a medical condition.
No
The device is a physical examination glove, which is a hardware medical device, 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 prevent contamination between patient and examiner by being worn on the hand or finger. This is a physical barrier function, not a diagnostic test performed on a sample from the human body.
- Device Description: The description focuses on the physical properties and standards met for a glove.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting substances, or providing diagnostic information about a patient's health condition.
- Performance Studies: The performance studies focus on the physical integrity and biocompatibility of the glove, not on diagnostic accuracy or analytical performance.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This examination glove does not fit that description.
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.
Product codes
LZA
Device Description
Powder free black nitrile patient examination glove, that meets all the requirements of ASTM standard D6319, except for sterility requirements.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hand or finger (examiner's)
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The Black Powder Free Nitrile Patient Exam Glove meets the requirements of established standards ASTM D6319-10, ASTM D6124-06, ASTM D5151-06, and ISO 10993-10:2010.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
-Dimension: ASTM D6319-10 (Meets)
-Physical Properties: ASTM D6319-10 (Meets)
-Freedom from Pinholes: ASTM D5151-06 & ASTM D6319-10 (Meets)
-Powder Residual: ASTM D6124-06 (Meets, Results generated values below 2mg of residual powder)
-Biocompatibility: 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)
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
1 Traditional 510(k) Premarket Notification ' ' Black Powder Free Nitrile Patient Exam Glove
510(k) Summary Page 1
K 121529
ﺮ ﺗﺮ
510(k) SUMMARY
February 17, 2012 DATE:
OWNER:
4
Northstar Healthcare Holdings 70 Sir John Rogerson's Quay Dublin 2, Ireland
JUL 1 2 2012
OFFICIAL CORRESPONDENT: Alex Nagy Manager, Quality Systems and Regulatory Affairs Cypress Medical Products LLC 1200 South Route 31 McHenry, IL 60050 Telephone: 815-385-0100 Fax: 815-385-0114 DEVICE NAME: Trade Name: Black Powder Free Nitrile Patient Exam Glove Common Name: Patient Examination Gloves Classification: Patient Examination Gloves Class: Class I
Product Code:
PREDICATE DEVICE(S):
| Predicate
510(k) | Device Name | Indication | Clearance
Date | Company |
|---------------------|------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------|-----------------------------------------------------------------------------|
| K060724 | Nitrile Powder
Free Examination
Gloves (Black and
Gray) | The examination glove is a disposable
device intended for medical purposes
that is worn on the examiner's hand to
prevent contamination between patient
and examiner. | 17 May 2006 | Smart
Glove Corp.
SDN BHN.
Selangor
Darul
Ehsan,
Malaysia |
DEVICE DESCRIPTION: Powder free black nitrile patient examination glove, that meets all the requirements of ASTM standard D6319, except for sterility requirements.
LZA
1
Traditional 510(k) Premarket Notification Black Powder Free Nitrile Patient Exam Glove
K121529
51,0(k) Summary Page 2
، ﺗ
STATEMENT OF INTENDED USE:
The nitrile examination glove is a disposable device intended for medical purposes to be worn on the examiner's hand or finger to prevent contamination between patient and examiner.
TECHNOLOGICAL The Black Powder Free Nitrile Patient Exam Glove CHARACTERISTICS: is substantially equivalent to the predicate device with regard to physical characteristics, design, product features, and intended use. Both gloves are made with Nitrile using similar manufacturing processes.
ASSESSMENT OF NONCLINICAL DATA:
| Characteristic | Standard | Device Performance |
|---|---|---|
| Dimension | ASTM D6319-10 | Meets |
| Physical Properties | ASTM D6319-10 | Meets |
| Freedom from Pinholes | ASTM D5151-06 & ASTM | |
| D6319-10 | Meets | |
| Powder Residual | ASTM D6124-06 | Meets |
| Results generated | ||
| values below 2mg of | ||
| residual powder | ||
| Biocompatibility | Primary Skin Irritation in rabbits | |
| (ISO 10993-10:2010) |
Dermal Sensitization in the guinea
pig (ISO 10993-10:2010) | Gloves are non-
irritating
Gloves do not display
any potential for
sensitization |
CONCLUSIONS: The Black Powder Free Nitrile Patient Exam Glove meets the requirements of established standards ASTM D6319-10, ASTM D6124-06, ASTM D5151-06, and ISO 10993-10:2010.
Based on the comparison of intended use, design, materials and performance, the Black Powder Free Nitrile Patient Exam Glove is substantially equivalent to the predicate device.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like symbol with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Northstar Healthcare Holdings C/O Mr. Ned Devine Responsible Third Party Official Underwriters Laboratories, Incorporated 333 Pfingsten Road Northbrook, Illinois 60062
JUL 12 2012
Re: K121529
Trade/Device Name: Black Powder Free Nitrile Patient Exam Glove Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: June 27, 2012 Received: June 28, 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.
3
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/ResourcesforYou/Industry/default.htm.
Sincerely yours.
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
4
Page 1_of 1
INDICATIONS FOR USE
510(k) Number (if known): K121529
Black Powder Free Nitrile Patient Exam Glove Device Name:
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.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
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)
(Division Sign-Off)
Division of Anesthesiology, General Hospital
Infection Control, Dental Devices
Page1 of1
510(k) Number: K121529