(313 days)
Not Found
No
The 510(k) summary describes a standard nitrile examination glove and does not mention any AI or ML capabilities. The performance studies focus on physical properties and biocompatibility, not algorithmic performance.
No
The device, Nitrile Examination Gloves, is intended for medical purposes to prevent contamination between the examiner and the patient, not to treat or diagnose a disease or condition.
No
The device, a Nitrile Examination Glove, is intended to prevent contamination between the examiner and the patient, and its performance characteristics are related to its physical properties and biocompatibility, not its ability to diagnose a condition.
No
The device is a physical examination glove, not a software application. The description focuses on material properties and performance characteristics of a tangible product.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is "worn on the examiner's hand or finger to prevent contamination between the examiner and the patient." This is a barrier function for personal protection and infection control.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections. This device does not perform any such test.
- Device Description: The description focuses on the physical properties and standards met by the glove, not on any diagnostic capabilities.
- Lack of Diagnostic Information: The document does not mention any diagnostic targets, analytes, or testing procedures.
The device described is a medical glove, which is a Class I or Class II medical device depending on its intended use and characteristics, but it is not an IVD.
N/A
Intended Use / Indications for Use
Non-Sterile, Powder-Free, Nitrile Examination Gloves, Blue is a disposable device intended for medical purposes that is worn on the examiner 's hand or finger to prevent contamination between the examiner
Non-Sterile, Powder-Free, Nitrile Examination Gloves, Blue is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between the patient and the examiner.
Product codes (comma separated list FDA assigned to the subject device)
LZA
Device Description
The subject device of this submission is a Nitrile Examination Glove. The glove is non-sterile and meets the recommendations of ASTM 6319-10. The device is Blue in color.
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The device was tested against the following standards:
- Dimensions: ASTM D 6319-10, Inspection Level-S-2 AQL4.0
- Physical Properties: ASTM D 6319-10, Inspection Level-S-2 AQL4.0
- Freedom from Pinholes – Water Tight Test 1000ML: ASTM D 6319-10, ASTM D 5151-06, Inspection Level-G-1 AQL 1.5
- Powder-Free Residue: ASTM D 6319-10, ASTM D 6124-06, Maximum 2mg/glove
- Biocompatibility: Dermal Sensitization (as per ISO 10993-10) - Not a contact skin sensitizer; Primary Skin Irritation Test (as per 16 CFR Part 1500) - Not a primary skin irritant
The subject device K162510, when compared to the predicate device K112012, showed:
- Similar material (Nitrile) and color (Blue).
- Similar biocompatibility test results: ISO 10993-10 - Primary Irritation Test (non-irritating) and ISO 10993-10 - Dermal Sensitization Assay (non-sensitizer).
- Similar tensile strength (Before Aging-min 14.0 MPa, After Aging-min 14.0 MPa) and elongation (Before Aging-min 500%, After Aging-min 400%).
- Similar waterleak AQL 1.5.
- Similar powder content (Max 2.0mg/glove, Avg 1.0mg/glove for subject device vs. Max 2.0mg/glove, Avg .22mg/glove for predicate).
- Both are Non-Sterile Examination Gloves designed for single use and have the same indications for use.
- Both have the same AQL 1.5 for pinholes.
The conclusion states that the product is as safe, as effective, and performs as well or better than the legally marketed device K112012.
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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a human figure with three heads in profile, representing the department's focus on health and well-being. The figure is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA", which is arranged in a circular pattern around the figure.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 18, 2017
UG Global Resources Sdn. Bhd. % Kenneth Stanton President UG Healthcare (USA) Inc. 1565 Sunflower Ave Costa Mesa, California 92626
Re: K162510
Trade/Device Name: Non-Sterile, Powder-Free, Nitrile Examination Gloves, Blue Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: Class I Product Code: LZA Dated: June 20, 2017 Received: January 19, 2017
Dear Kenneth Stanton:
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.
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) 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 contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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,
Mark S. Fellman -S
for
Lori Wiggins, MPT, CLT Acting Director Division of Anesthesiology, General Hospital. Respiratory. Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K162510
Device Name
Non-Sterile, Powder-Free, Nitrile Examination Gloves, Blue
Indications for Use (Describe)
Non-Sterile, Powder-Free, Nitrile Examination Gloves, Blue is a disposable device intended for medical purposes that is worn on the examiner 's hand or finger to prevent contamination between the examiner
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
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SUMMARY
PREMARKET 510(k) NOTIFICATION Non-Sterile, Powder-Free, Nitrile Examination Gloves, Blue K162510
Submission Applicant:
UG Global Resources Sdn Bhd 1st Floor No. 18 Jalan Dato'Abd Rahman 70000 Seremban Negeri Sembilan Darul Khusus, Malaysia Telephone No .: 60-06-6772751 Fax:60-06-6772755
Official Correspondent: Kenneth J. Stanton, President UG Healthcare (USA) Inc. 1565 Sunflower Avenue Costa Mesa, Ca 92626 Tel: (714)444-2248 Fax: (714)444-2271
Date: June 8, 2017
Description of the Device: Non-Sterile, Powder-Free, Nitrile Examination Gloves, Blue
Trade Name: Non-Sterile, Powder-Free, Nitrile Examination Gloves, Blue
Common Name: Nitrile Examination Gloves Classification Name: Patient Examination Glove (per 21 CFR 880.6250) Class 1: Powder-Free Nitrile examination glove LZA that meets all of the requirements of ASTM 6319-10.
Predicative Devices (K112012):Non-Sterile, Powder-Free, Blue, Nitrile Examination Gloves
Device Description: The subject device of this submission is a Nitrile Examination Glove. The glove is non-sterile and meets the recommendations of ASTM 6319-10 . The device is Blue in color.
Indications for Use: Non-Sterile, Powder-Free, Nitrile Examination Gloves, Blue is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between the patient and the examiner.
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SUMMARY
PREMARKET 510(k) NOTIFICATION
Non-Sterile, Powder-Free, Nitrile Examination Gloves, Blue
Summary of Technological Characteristics:
Material: Nitrile Cuff: Beaded Powder Residue: Maximum 2mg/glove
| Characteristics | Standards | Device Performance |
|---|---|---|
| Dimensions | ASTM D 6319-10 | Inspection Level-S- |
| 2 AQL4.0 | ||
| Physical Properties | ASTM D 6319-10 | Inspection Level-S-2 |
| AQL4.0 | ||
| Freedom from Pinholes – Water Tight | ||
| Test 1000ML | ASTM D 6319-10 | |
| ASTM D 5151-06 | Inspection Level-G-1 | |
| AQL 1.5 | ||
| Powder-Free Residue- | ASTM D 6319-10 | |
| ASTM D 6124-06 | Maximum 2mg/glove | |
| Biocompatibility | Dermal Sensitization | |
| (as per ISO 10993-10) | Not a contact skin sensitizer | |
| Primary Skin Irritation Test | ||
| (as per 16 CFR Part 1500) | Not a primary skin irritant |
Packaging: 100 pieces per dispenser box, 10 boxes per case, 1,000 gloves per case
Sizes: XS -XL
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Substantial Equivalence Table-
| | Color | Material | Biocompatibility Tests | ASTM D3578-05(2015)
Tensile Strength (MPa) | ASTM D3578-
05(2015)
Elongation % |
|--------------------------------|-------|----------|----------------------------------------------------------------------------------------------------------------------|-----------------------------------------------|-----------------------------------------|
| Subject
Device
K162510 | Blue | Nitrile | ISO 10993-10 - Primary Irritation Test- Under the
conditions of the study, the device is non-irritating | Before Aging- min 14.0 | Before Aging - min
500 |
| | | | ISO 10993-10 - Dermal Sensitization Assay -
Under the conditions of the study, the device is a
non-sensitizer | After Aging - min 14.0 | After Aging - min.
400 |
| Predicate
Device
K112012 | Blue | Nitrile | ISO 10993-10 - Dermal Sensitization Assay - Under
the conditions of the study, the device is a non-
sensitizer | Before Aging- min 14.0 | Before Aging- min.
500 |
| | | | ISO 10993-10 - Primary Irritation Test- Under the
conditions of the study, the device is non-irritating | After Aging- min 14.0 | After Aging - min.
400 |
| Subject Device | Dimensions | Waterleak | Powder Content | ||
|---|---|---|---|---|---|
| K162510 | Palm Width - 95mm +/-10 Medium size | ||||
| Length: 240mm min | |||||
| Thickness: Min .05mm Palm and finger | AQL 1.5 | Max 2.0mg/glove | |||
| Avg 1.0mg/glove | |||||
| K112012 | Palm Width- 95mm +/- 10 Medium size | ||||
| Length: 240mm min | |||||
| Thickness: Min .15mm Palm and Min .17mm finger | AQL 1.5 | Max 2.0mg/glove | |||
| Avg .22mg/glove |
| Sizes | Single Use | Indications for Use | |
|---|---|---|---|
| Subject | |||
| Device | |||
| K162510 | XS-XL | Yes | A 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 | |||
| Predicate | |||
| Device | |||
| K112012 | XS-XL | Yes | A 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 |
Comparisons-Both K162510 and K112012 are Non-Stelle Examination Gloves. Both have the same specifications exept for thickness, both have the same AQ. 1.5 for pinholes and similar powder content. Both gloves have be matility Test. Additionally, both devices have similar tensile strength and elongation performance.
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Conclusion:
This product is as safe, as effective, and performs as well or better than the legally marketed device K112012 (Non-Sterination Gloves),