(170 days)
Not Found
No
The device description and performance studies focus on the physical properties and biocompatibility of examination gloves, with no mention of AI or ML.
No
The device is an examination glove intended to prevent contamination, not to treat or cure a disease or condition, which is the definition of a therapeutic device.
No
The device is an examination glove, which is intended to prevent contamination between patient and examiner. It does not provide any diagnostic information or analysis.
No
The device is described as physical examination gloves made of nitrile, which are hardware. The summary focuses on physical properties and biocompatibility testing, not software functionality.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the glove is for preventing 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 body.
- Device Description: The description details the material, sterility, and packaging of the glove. It doesn't mention any reagents, test strips, or other components typically associated with IVDs.
- Lack of IVD Characteristics: The document does not mention any of the key characteristics of an IVD, such as:
- Analyzing a sample (blood, urine, tissue, etc.)
- Detecting or measuring a substance in a sample
- Providing information for diagnosis, monitoring, or screening
- Performance Studies: The performance studies focus on the physical properties, freedom from pinholes, powder residual, and biocompatibility of the glove – all relevant to its function as a barrier, not as a diagnostic tool.
In summary, this device is a medical glove, which is a Class I or Class II medical device depending on its intended use and characteristics, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Textured Blue Sterile Powder Free Nitrile Examination Gloves 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.
Product codes
LZA
Device Description
Sterile, powder free, examination gloves made of nitrile. The gloves are provided in sizes small, medium, and large.
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
medical and dental purposes
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 Textured Blue Sterile Powder Free Nitrile 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.)
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 Sterile Nitrile Powder Free Examination Gloves Section 5, 510(k) Summary Page 1 of 3
FEB 2 2 2013
510(k) SUMMARY 5.
OFFICIAL CORRESPONDENT:
DATE:
OWNER:
September 20, 2012
Northstar Healthcare Holdings 70 Sir John Rogerson's Quay Dublin 2, Ireland
Michael Riordan Operations Manager Telephone: 00353-21-4548255 Fax: 00353-21-4548294 Email: michael.riordan@mckesson.ie
DEVICE NAME:
| Trade Name: | Textured Blue Sterile Powder Free Nitrile
Examination Gloves |
|--------------------|-----------------------------------------------------------------|
| Common Name: | Patient Examination Gloves |
| Classification: | Patient Examination Gloves |
| Class: | Class I |
| Product Code: | LZA |
| Regulation Number: | 880.6250 |
PREDICATE DEVICE(S):
| Predicate
510(k) | Device Name | Indication | Clearance
Date | Company |
|---------------------|------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------|-----------------------------------|
| K081466 | Sterile Nitrile Powder
Free 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. | 30 Jul 2008 | Smart Glove
Corp., SDN.
BHD |
DEVICE DESCRIPTION: Textured Blue Sterile Powder Free Nitrile Examination Gloves
. .
1
Abbreviated 510(k) Premarket Notification Sterile Nitrile Powder Free Examination Gloves Section 5, 510(k) Summary Page 2 of 3
STATEMENT OF INTENDED USE:
The Textured Blue Sterile Powder Free Nitrile Examination Gloves 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 Textured Blue Sterile Powder Free Nitrile Examination Gloves 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 | Sterile Nitrile Powder Free Examination Gloves
K081466
Predicate | Textured Blue Sterile Powder Free Nitrile
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 | Sterile, powder free, examination gloves made of nitrile. The gloves are
provided in sizes extra small, small, medium, large and extra large. | Sterile, powder free, examination gloves made of
nitrile. The gloves are provided in sizes small,
medium, and large. |
| Presentation | Sterile gloves are provided in dispenser boxes. | Same |
| Material | Nitrile | Same |
| Sterilization | Sterile | Same |
| Single Use | Yes | Same |
| Dimensions | Meets ASTM D6319-00a(2005) | Length
Small 230mm min.
Medium 230mm min.
Large 230mm min.
Width
Small 70-90mm
Medium 85-105mm
Large 101-120mm
Thickness Finger 0.08mm min.
Palm 0.06mm min. |
| Physical
Properties | Meets ASTM D6319-00a(2005) | Before aging/after aging
Elongation 500% 400%
Tensile Strength 14MPa 14MPa |
| Freedom from
Pinholes | Meets ASTM D5151-06 | Same |
| Residual
Powder | Meets ASTM D6124-06 | Same |
2
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 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 Textured Blue Sterile Powder Free Nitrile 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 Textured Blue Sterile Powder Free Nitrile Examination Gloves 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 features a stylized eagle with three stripes forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 22, 2013
Northstar Healthcare Holdings C/O Mr. Ned Devine Responsible Third Party Official Underwriters Laboratories, Incorporated 333 Pfingsten Road NORTHBROOK IL 60062
Re: K122727
Trade/Device Name: Textured Blue Sterile Powder Free Nitrile Examination Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: February 7, 2013 Received: February 8, 2013
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/CDRH0ffices/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.
Image /page/4/Picture/7 description: The image shows a stylized graphic with illegible text. The text appears to be handwritten and overlaid on top of a geometric design. The design includes a maze-like pattern on the left and a triangular shape on the right, both rendered in black lines.
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): K122727
Textured Blue Sterile Powder Free Nitrile Examination Gloves 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)
Elizabeî 2013.02
(Division Sign-Off) Division of Anesthesloiogy, General Hospital Infection Control, Dental Devices
510(k) Number;_
Page 1 of 1
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Northstar Healthcare Holdings