(40 days)
Not Found
No
The device description and intended use clearly indicate a standard examination glove, with no mention of AI/ML technology or any features that would require such capabilities. The performance studies focus on physical properties and biocompatibility, typical for this type of device.
No
The device is an examination glove, which is intended to prevent contamination, not to treat or cure a disease or condition.
No
The device is described as an examination glove intended to prevent contamination, not to diagnose a condition.
No
The device is described as a physical examination glove made of nitrile, which is a hardware component, 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 taken from the body.
- Device Description: It's described as a "Nitrile Powdered patient examination glove." This is a physical barrier device.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in a sample
- Providing information for diagnosis, monitoring, or screening of diseases or conditions.
- Performance Studies: The performance studies focus on physical properties, freedom from pinholes, powder residual, and biocompatibility – all relevant to a physical barrier device, not an IVD.
Therefore, this device falls under the category of a medical device, specifically an examination glove, but not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Nitrile Powdered Examination Glove is a Disposable device intended for medical and dental purposes to be worn on the examiner's hand or finger to prevent contamination between patient and examiner.
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
Nitrile Powdered patient examination glove
The powdered examination gloves made of nitrile. The gloves are provided in sizes small, medium, large, and extra large.
Gloves are provided in dispenser boxes.
Material: Nitrile
Sterilization: Non-sterile
Single Use: Yes
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hand or finger
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 Nitrile Powdered Examination Gloves meet the requirements of established standards ASTM D6319-10, ASTM D5151-06, ASTM D6124-06 and ISO 10993-10:2010.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Elongation 500% 500%
Tensile Strength 14MPa 14MPa
Powder Residual results generated values below 10 mg/dm² of powder
Gloves are non-irritating
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
Abbreviated 510(k) Premarket Notification Nitrile Powdered Examination Gloves
K122998 Section 5, 510(k) Summary Page 1 of 3
- 510(k) SUMMARY
| DATE: | February 17, 2012 |
|---|---|
| OWNER: | Northstar Healthcare Holdings |
| 70 Sir John Rogerson's Quay | |
| Dublin 2, Ireland |
NOV 6 2012
| OFFICIAL CORRESPONDENT: | Michael Riordan
Operations Manager
Telephone: 00353-21-4548255
Fax: 00353-21-4548294
Email: michael.riordan@mckesson.ie |
|-------------------------|-------------------------------------------------------------------------------------------------------------------------------------|
| DEVICE NAME: | Trade Name: Textured, Blue Powdered Nitrile Examination Glove |
| | Common Name: Patient Examination Gloves |
| | Classification: Patient Examination Gloves |
| | Class: Class I |
| | Product Code: LZA |
PREDICATE DEVICE(S):
| Predicate
510(k) | Device Name | Indication | Clearance
Date | Company |
|---------------------|----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------|-----------------------------------|
| K974907 | Nitrile Powdered
Examination Gloves | The examination glove 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. | 13 Mar 1998 | Smart Glove
Corp., SDN,
BHD |
DEVICE DESCRIPTION: Nitrile Powdered patient examination glove
1
Section 5, 510(k) Summary Page 2 of 3
STATEMENT OF INTENDED USE:
The Nitrile Powdered Examination Glove is a Disposable device intended for medical and dental purposes to be worn on the examiner's hand or finger to prevent contamination between patient and examiner.
TECHNOLOGICAL CHARACTERISTICS:
The Nitrile Powdered 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 nitrile using similar manufacturing processes.
| Feature | Nitrile Powdered Examination Gloves
K974907
Predicate | Textured, Blue Nitrile Powdered Examination Gloves
Proposed |
|----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Intended for medical purposes that is worn on the
examiner's hand to prevent contamination between patient
and examiner. | Same |
| Indications for
Use Statement | The examination glove 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. | 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. |
| Description | The powdered examination gloves made of nitrile. The
gloves are provided in sizes extra small, small, medium,
large and extra large. | The powdered examination gloves made of nitrile. The gloves
are provided in sizes small, medium, large, and extra large. |
| Presentation | Gloves are provided in dispenser boxes. | Same |
| Material | Nitrile | Same |
| Sterilization | Non-sterile | Same |
| Single Use | Yes | Same |
| Dimensions | Meets ASTM D3578-95 | Length Small 230 mm min.
Medium 230 mm min.
Large 230 mm min.
Extra Large 230 mm min.
Width Small 80-90 mm
Medium 90-100 mm
Large 100-110 mm
Extra Large 110-120 mm |
| | | Thickness Finger 0.08 mm min.
Palm 0.06mm min |
| Physical
Properties | Meets ASTM D3578-95 | Before aging/after aging
Elongation 500% 500%
Tensile Strength 14MPa 14MPa |
| Freedom from
Pinholes | Meets ASTM D5151-92 | Meets ASTM D5151-06 |
| Residual Powder | Meets ASTM D6124-97 | Meets ASTM D6124-06 |
2
Page 3 of 3
Section 5, 510(k) Summary
Abbreviated 510(k) Premarket Notification Nitrile Powdered Examination Gloves
ASSESSMENT OF NONCLINICAL DATA:
| Characteristic | Standard | Device Performance |
|---|---|---|
| Dimension | ASTM Standard D6319-10 | Meets |
| Physical Properties | ASTM Standard D6319-10 | Meets |
| Freedom from | ||
| Pinholes | 21 CFR 800.20; ASTM D5151- | |
| 06 | Meets | |
| Powder Residual | ASTM Standard D6124-06 | Meets |
| Results generated | ||
| values below 10 | ||
| mg/dm² of 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 |
CONCLUSIONS:
The Nitrile Powdered Examination Gloves meet the requirements of established standards ASTM D6319-10, ASTM D5151-06, ASTM D6124-06 and ISO 10993-10:2010.
Based on the comparison of intended use, design, materials and performance, the Nitrile Powdered Examination Gloves are substantially equivalent to the predicate device.
3
Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The text is in all caps and is oriented to follow the curve of the circle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
November 6, 2012
Northstar Healthcare Holdings C/O Underwriters Laboratories, Incorporated Mr. Ned Devine 333 Pfingsten Road Northbrook, Illinois 60062
Re: K122998
Trade/Device Name: Textured Blue Powdered Nitrile Examination Glove Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: October 19, 2012 Received: October 22, 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,
Digitally signed by Anthony D. Watson DN: c=US, o=U.S. Government, ou=HHHS, ou=FDA, ou=People, cn=Anthony D. Watson, 0.9.2342.19200300.100.1.1=1300092402 Date: 2012.11.06 14:26:52 -05/00'
Anthony D. Watson, B.S., M.S., M.B.A. Director
Division of Anesthesiology, General Hospital, Respiratory, 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): K122998
Device Name: Textured Blue Powdered Nitrile Examination Glove
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.
AND/OR
Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (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)
for ECW
(Division Sign-Off)
(Division Sign-On)
Division of Anesthesiology, General Hospital Division Control, Dental Devices
510(k) Number: K122998
Page 1 of 1
Northstar Healthcare Holdings