(69 days)
Not Found
No
The device is a standard examination glove and the description and performance studies focus on material properties and safety, with no mention of AI or ML.
No
The device is described as an "examination glove" intended to prevent contamination between patient and examiner, which is a barrier function, not a therapeutic one. It does not treat, diagnose, cure, or mitigate any disease or condition.
No
The device is described as an examination glove intended to prevent contamination between the patient and examiner, not to diagnose a condition.
No
The device description clearly states it is a physical examination glove made of nitrile, which is a hardware component. The performance studies also focus on physical properties and biocompatibility of the glove material.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states the device is an "examination glove" worn on the hand or finger to prevent contamination. Its purpose is a physical barrier, not to analyze biological samples.
- Intended Use: The intended use is for "medical purposes" as a barrier, not for diagnostic testing.
- Device Description: The description focuses on the physical properties of the glove (material, color, size, texture, powder-free) and its compliance with standards related to gloves, not diagnostic tests.
- Performance Studies: The performance studies listed assess the physical and biological properties of the glove itself (dimensions, strength, pinholes, powder, biocompatibility), not the accuracy or performance of a diagnostic test.
Therefore, based on the provided information, this examination glove is a medical device, but it does not fit the definition of an In Vitro Diagnostic.
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 (comma separated list FDA assigned to the subject device)
LZA
Device Description
Powder free blue nitrile patient exam glove, 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
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The ETS Blue Powder Free Nitrile Patient Exam Gloves meet the requirements of established standards ASTM D6319-10, ASTM D6124-06, ASTM D5151-06, and ISO 10993-10.
Nonclinical data testing included:
Dimension: ASTM D6319 - Meets
Physical Properties: ASTM D6319 - Meets
Freedom from Pinholes: ASTM D6319 & ASTM D5151 - Meets
Powder Residual: ASTM D6124 - Meets (Results generated values below 2mg of residual powder)
Biocompatibility: Primary Skin Irritation in rabbits (ISO 10993-10) - Gloves are non-irritating; Dermal Sensitization in the guinea pig (ISO 10993-10) - Gloves do not display any potential for sensitization
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
510(k) SUMMARY
DATE:
OWNER:
February 17, 2012
SEP 10 2012
Northstar Healthcare Holdings 70 Sir John Rogerson's Quay Dublin 2, Ireland
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: | ETS Blue Powder Free Nitrile Patient Exam 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 |
|---------------------|------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------|--------------------------------------------------------------------------------------|
| K062764 | Nitrile Powder Free
Examination Gloves
(White, Blue) | The patient 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. | 27 Feb 07 | Kossan
Latex
Industries
SDN BHN.
Selangor
Darul
Ehsan,
Malaysia |
DEVICE DESCRIPTION: Powder free blue nitrile patient exam glove, meets all the requirements of ASTM standard D6319, except for sterility requirements.
Northstar Healthcare Holdings
1
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 CHARACTERISTICS: The ETS Blue Powder Free Nitrile Patient Exam 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 Powder Free Examination Gloves Tested
for Use with Chemotherapy Drugs (Blue,
White)
K062764
Predicate | ETS Blue Powder Free Nitrile
Patient Exam Gloves
Proposed |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Intended for medical purposes that is worn on
the examiner's hand to prevent contamination
between patient and examiner. Tested for Use
with Chemotherapy Drugs. | Intended for medical purposes that
is worn on the examiner's hand to
prevent contamination between
patient and examiner. |
| Indications for Use
Statement | The patient 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.
This device is not intended to be used as a
chemical barrier. | 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 | Non-sterile, powder free, examination gloves
made of nitrile and colored white. The textured
gloves are provided in sizes extra small, small,
medium, large and extra large. The smooth
gloves are provided in sizes small, medium,
large and extra large. | Same |
| Presentation | Non-sterile gloves are provided in dispenser
boxes. | Same |
| Material | Nitrile | Same |
| Sterilization | Non-sterile | Same |
| Single Use | Yes | Same |
| Ambidextrous | Yes | Same |
| Dimensions | Meets ASTM D6319-10 | Same |
| Tensile Strength | Meets ASTM D6319-10 | Same |
| Ultimate Elongation | Meets ASTM D6319-10 | Same |
| Freedom from
Pinholes | Meets ASTM D5151-06 and ASTM D6319-10 | Same |
| Residual Powder | Meets ASTM D6124-06 | Same |
| Biocompatibility | Passes Primary Skin Irritation in Rabbits | Same |
| Tests | Passes Closed Patch Sensitization in Guinea Pigs | Same |
Northstar Healthcare Holdings
2
ASSESSMENT OF NONCLINICAL DATA:
| Characteristic | Standard | Device Performance |
|---|---|---|
| Dimension | ASTM D6319 | Meets |
| Physical Properties | ASTM D6319 | Meets |
| Freedom from Pinholes | ASTM D6319 & ASTM D5151 | Meets |
| Powder Residual | ASTM D6124 | Meets |
| Results generated values | ||
| below 2mg of residual | ||
| powder | ||
| Biocompatibility | Primary Skin Irritation in rabbits | Gloves are non-irritating |
| (ISO 10993-10) | ||
| Dermal Sensitization in the guinea | Gloves do not display any | |
| pig (ISO 10993-10) | potential for sensitization |
CONCLUSIONS:
The ETS Blue Powder Free Nitrile Patient Exam Gloves meet the requirements of established standards ASTM D6319-10, ASTM D6124-06, ASTM D5151-06, and ISO 10993-10.
Based on the comparison of intended use, design, materials and performance, the ETS Blue Powder Free Nitrile Patient Exam Gloves are substantially equivalent to the predicate device.
3
Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.
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 Senior Staff Engineer Underwriters Laboratories, Incorporated 333 Pfingsten Road Northbrook, Illinois 60062
SEP 10 2012
Re: K121947
Trade/Device Name: ETS Blue Powder Free Nitrile Patient Exam Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LZA Dated: August 28, 2012 Received: August 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.
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 Q. Shem.D.
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): _ K 12 1947
ETS Blue 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 _ (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 |
Page 1 of _510(k) Number: