(200 days)
No
The device is a patient examination glove and the description focuses on material properties and physical characteristics, with no mention of AI or ML.
No.
The device is an examination glove intended to prevent contamination between patient and examiner, not to treat or diagnose a disease or condition.
No
Explanation: The device is an examination glove, intended to prevent contamination between patient and examiner. It is not used for obtaining information for diagnosing, treating, or preventing disease.
No
The device is a physical glove made of nitrile butadiene rubber with coatings, 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 clearly stated as "worn on the examiners hands to prevent contamination between patient and examiner." This is a barrier function, not a diagnostic test performed on a sample taken from the body.
- Device Description: The description details the physical characteristics and materials of a glove. There is no mention of reagents, assays, or any components used to analyze biological samples.
- Lack of Diagnostic Function: The device does not perform any test or analysis to provide information about a patient's health status, disease, or condition.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body (such as blood, urine, tissue, etc.) to provide information for diagnostic, monitoring, or screening purposes. This glove does not fit that description.
N/A
Intended Use / Indications for Use
Micro Touch Denta Glove Nitrile Hydrasoft Patient Examination Gloves are intended for medical purposes that are worn on the examiners hands to prevent contamination between patient and examiner.
Product codes (comma separated list FDA assigned to the subject device)
LZA
Device Description
The MICRO-TOUCH® DENTA-GLOVE® Nitrile HydraSoft™ are non-sterile, single use only, disposable, powder free examination gloves. The glove is made of nitrile butadiene rubber. A polyacrylic polymer is applied to the inner surface of the glove to make donning easy. Hydrasoft coating (containing glycerine) is applied on top of the polymer coating on the glove inner surface..
Characteristic:
- Ambidextrous with beaded cuff and straight fingers
- Finger-textured,
- White colored
- Featuring inner coating of polyacrylic polymer coating and HydraSoft™ coating.
- . Five (5) sizes – extra-small, small, medium, large, and extra-large.
High levels of ozone will degrade rubber material of the glove, therefore the glove should be protected from ozone in particular.
The gloves are designed to meets the specifications of ASTM D6319-10, Standard Specification for Nitrile Examination Gloves for Medical Application.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hands
Indicated Patient Age Range
Not Found
Intended User / Care Setting
examiner / 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)
A clinical study was not conducted on the subject or predicate devices.
The subject device meets the applicable requirements for patient examination gloves regarding dimensions and sizes, physical properties, freedom from holes, and powder residues as found in the following standards: ASTM D6319, ASTM D5151 and ASTM D6124. The subject device passes biological reactivity testing for dermal sensitization and irritation, in accord with the ISO 10993 series of standards.
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.
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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 29, 2017
Ansell Healthcare Products LLC Robert Mahler Director, Regulatory Affairs for the Americas 111 Wood Avenue South, Suite 210 Iselin, New Jersey 08830
Re: K171737
Trade/Device Name: Micro Touch Denta Glove Nitrile Hydrasoft Patient Examination Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: Class I Product Code: LZA Dated: December 8, 2017 Received: December 11, 2017
Dear Robert Mahler:
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.
1
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 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.
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.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Tina Kiang
-s
Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K171737
Device Name
Micro Touch Denta Glove Nitrile Hydrasoft Patient Examination Glove
Indications for Use (Describe)
Micro Touch Denta Glove Nitrile Hydrasoft Patient Examination Gloves are intended for medical purposes that are worn on the examiners hands to prevent contamination between patient and examiner.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CER 801 Subnart D) | Over-The-Counter Use (21 CFR 801 Subnart C) |
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3
510k Summary
510(k): K171737
Submitter:
Ansell Healthcare Products LLC. 111 Wood Avenue South, Suite 210 Iselin, NJ 08830 USA
Contact Person:
Robert Mahler Director, Regulatory Affairs for the Americas Phone: (732) 345-2174 Email: rob.mahler@ansell.com
Date Prepared:
12/8/2017
Name of the Device:
| Trade Names: | Micro Touch Denta Glove Nitrile Hydrasoft Patient Examination Gloves | |
|---|---|---|
| Common Name: | Patient Examination Glove | |
| Classification Name: | Patient Examination Glove | |
| Classification Regulation: | 21 CFR 880.6250 | |
| Device Class: | 1 | |
| Product Code: | LZA | |
| Classification Panel: | General and Plastic Surgery | |
| Legally Marketed Predicate Device: | ||
| Company: | Wear Safe (Malaysia) Sdn Bhd | |
| Trade Name: | Powder Free Nitrile Patient Examination Glove, Blue Colored and White (Non- | |
| colored), Non-sterile, Polymer Coated | ||
| Powder Free Nitrile Patient Examination Gloves, Blue Colored and white (Non- | ||
| colored), Non-sterile, without Polymer (Chlorinated) | ||
| 510(k) Number: | K123469 | |
| Device Class: | Class I |
| 510(k) Number: | K123469 |
|---|---|
| Device Class: | Class I |
| Product Code: | LZA (Nitrile) |
| Device Name: | Patient Examination Glove (21 CFR 880.6250) |
Reference Device:
| Company: | Ansell Healthcare LLC |
|---|---|
| Trade Name: | Encore Sterile Powder-Free Polymer Coated Latex Surgical Glove with Hydrasoft™ |
| Coating (containing glycerine) and Protein Labeling Claim (50mg or less) | |
| 510(k) Number: | K051793 |
| Device Class: | Class I |
| Product Code: | KGO |
| Device Name: | Surgeon's Glove (21 CFR 878.4460) |
4
Device Description:
The MICRO-TOUCH® DENTA-GLOVE® Nitrile HydraSoft™ are non-sterile, single use only, disposable, powder free examination gloves. The glove is made of nitrile butadiene rubber. A polyacrylic polymer is applied to the inner surface of the glove to make donning easy. Hydrasoft coating (containing glycerine) is applied on top of the polymer coating on the glove inner surface..
Characteristic:
- Ambidextrous with beaded cuff and straight fingers
- Finger-textured,
- White colored
- Featuring inner coating of polyacrylic polymer coating and HydraSoft™ coating.
- . Five (5) sizes – extra-small, small, medium, large, and extra-large.
High levels of ozone will degrade rubber material of the glove, therefore the glove should be protected from ozone in particular.
The gloves are designed to meets the specifications of ASTM D6319-10, Standard Specification for Nitrile Examination Gloves for Medical Application.
Indications for Use Statement:
A powder-free 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.
Technological Characteristics:
Micro Touch Denta Glove with Hydrasoft Coating Nitrile Patient Examination Gloves have the following technological characteristics as compared to ASTM or equivalent standards:
| Characteristics | Standard/Test/ | Result Summary |
|---|---|---|
| FDA Guidance | ||
| Physical Characteristics : | ||
| Dimensions: | ASTM D6319-10 | Meets ASTM D6319-10 requirements for length, |
| width and thickness | ||
| Length | Minimum 230mm | Minimum 240mm |
| Palm width (mm) | ||
| Size — XS | 70 ± 10 | 75 ± 5 |
| Size — S | 80 ± 10 | 85 + 5 |
| Size — M | 95 ± 10 | 95 + 5 |
| Size — L | 110± 10 | 105 + 5 |
| Size - XL | 120 ± 10 | 115 ± 5 |
| Thickness (mm) - single-wall | ||
| Finger | minimum 0.05 | Finger - 0.11 ± 0.03 |
| Palm | minimum 0.05 | Palm – 0.07 ± 0.02 |
| Cuff | Cuff -- 0.06 ± 0.02 |
5
Pre-market Notification: Traditional 510(k) Submission Micro-Touch Denta-Glove with HydraSoft Coating Nitrile Examination Glove
| Physical Properties: | ASTM D6319-10 | Meets ASTM D6319-10 requirements for tensile
strength and ultimate elongation before and after
accelerated aging: |
|-----------------------------------------|--------------------------------|------------------------------------------------------------------------------------------------------------------------------------|
| Tensile Strength | | |
| Before Aging | minimum 14 MPa | minimum 17 MPa |
| After Aging | minimum 14 MPa | minimum 17 MPa |
| Ultimate Elongation | | |
| Before Aging | minimum 500% | minimum 500% |
| After Aging | minimum 400% | minimum 400% |
| Freedom from holes | ASTM D6319-10
ASTM D5151-06 | Meets ASTM D6319-10 and ASTM D5151-06
requirements of AQL 2.5 |
| Powder Residual | ASTM D6319-10
ASTM D6124-06 | Meets applicable requirement for powder free; ≤
2 mg per glove |
| Biocompatibility: | | |
| ISO In Vitro
Cytotoxicity | ISO 10993-5:2009 | Under the conditions of the study, undiluted and
1:2 dilution was cytotoxic. 1:4, 1:8, 1:16, 1:32 and
1:64 are not cytotoxic |
| ISO Skin Irritation
Study | ISO10993-10:2010 | Under the conditions of the study, not an irritant |
| ISO Maximization
Sensitization Study | ISO 10993-10:2010 | Under the conditions of the study, not a
sensitizer |
| ISO acute systemic
toxicity | ISO 10993-11: 2006 | Under the conditions of the study, no evidence of
systemic toxicity |
Substantial Equivalence:
| Trade name | Predicate Device | Reference Device | Proposed Subject
Device | Substantial
Equivalence to
Predicate |
|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------|
| | Powder Free Nitrile
Patient Examination
Glove, Blue Colored,
and White (Non-
colored). Non-sterile,
Polymer Coated | Encore Sterile Powder-
Free Polymer Coated
Latex Surgical Glove
with Hydrasoft Coating
(containing glycerine)
and Protein Labeling
Claim (50mg or less) | MICRO-TOUCH®
DENTA-GLOVE® Nitrile
HydraSoft™ Non-
Sterile Powder-Free
Examination Glove | Not applicable |
| 510k Number | K123469 | K051793 | Pending | Not Applicable |
| Product Owner | Wear Safe Malaysia | Ansell Healthcare | Ansell Healthcare | Ansell Healthcare |
| Product Code | LZA | KGO | LZA | Same |
| Regulation
Number | 21 CFR 880.6250 | 21 CFR 878.4460 | 21 CFR 880.6250 | Same |
| Regulatory Class | 1 | 1 | 1 | Same |
| Regulation Name | Patient Examination
Glove | Surgeon's Glove | Patient Examination
Glove | Same |
| | | | | Iselin, NJ 088- |
| Intended Uses | 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 | The surgical glove is
intended to be worn by
operating room
personnel to protect a
surgical wound from
contamination. The
latex glove contain 50
micrograms or less of
water extractable per
gram | 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 | Same |
| Material
Composition | Synthetic nitrile rubber | Natural rubber latex | Synthetic nitrile rubber | Same |
| Coating | Polyacrylic polymer
inner coating to aid
donning | Polyurethane polymer
inner coating to aid
donning | Polyacrylic polymer
inner coating to aid
donning | Same |
| HydraSoft
Coating | N/A | HydraSoft™ Coating
coated on the donning
surface | HydraSoft™ Coating
coated on the donning
surface | Different from
predicate |
| Design | Non-sterile | Sterile | Non-sterile | Same |
| | Single use | Single use | Single use | Same |
| | Powder-free | Powder-free | Powder-free | Same |
| | Ambidextrous | Hand specific | Ambidextrous | Same |
| | Beaded cuff | Beaded cuff | Beaded cuff | Same |
| Color | White | White | White | Same |
| Shelf Life | 3 years | 3 years | 3 years | Same |
| Performance | | | | Same |
| a. Dimensions | Meets ASTM D6319-10
requirements | Meets ASTM 3577
requirements | Meets ASTM D6319-10
requirements | |
| b. Physical
Properties | Meets ASTM D6319-10
requirements | Meets ASTM 3577
requirements | Meets ASTM D6319-10
requirements | Same |
| c. Freedom from
holes | Meets ASTM D6319-10
requirements of GI, AQL
2.5 | Meets ASTM 3577
requirements
of GI, AQL 1.5 | Meets ASTM D6319-10
requirements of GI,
AQL 2.5 | Same |
| d. Powder
Residual | Meets ASTM D6319-10
requirements; Not
more than 2.0mg/glove | Meets ASTM 3577
requirements; Not more
than 2.0mg/glove | Meets ASTM D6319-10
requirements; Not
more than
2.0mg/glove | Same |
| e. Sterility | Non-sterile | Sterile | Non-sterile | Same |
| Biocompatibility | Passes Primary Skin
Irritation Test and
Dermal Sensitization
Test | Passes Primary Skin
Irritation Test and
Dermal Sensitization
Test | "Under the conditions
of the study, not an
irritant" and "Under
the conditions of the
study, not a sensitizer" | Same |
6
Pre-market Notification: Traditional 510(k) Submission Micro-Touch Denta-Glove with HydraSoft Coating Nitrile Examination Glove
The MICRO-TOUCH® DENTA-GLOVE® Nitrile HydraSoft™ are non-sterile, single use only, disposable, powder free patient examination gloves. The glove is made of nitrile butadiene rubber. A polyacrylic polymer is applied to the inner surface of the glove to make donning easy. Hydrasoft coating glycerine) is applied on top of the polymer coating on the glove inner surface.
7
The subject device meets the applicable requirements for patient examination gloves regarding dimensions and sizes, physical properties, freedom from holes, and powder residues as found in the following standards: ASTM D6319, ASTM D5151 and ASTM D6124. The subject device passes biological reactivity testing for dermal sensitization and irritation, in accord with the ISO 10993 series of standards.
Performance Data:
A clinical study was not conducted on the subject or predicate devices.
Substantial Equivalence Statement
The Micro-Touch Denta-Glove with HydraSoft Coating Nitrile Patient Examination Glove is as safe and effective as the predicate device with respect to design, technological characteristics, intended use and conformance to standard requirements.
Conclusion
The conclusions drawn from the non clinical tests demonstrate that theMicro-Touch Denta-Glove with HydraSoft Coating Nitrile Patient Examination Glove is as safe and effective as the legally marketed predicate device previously cleared under K123469, Class I (21 CFR 880.6250, Product Code: LZA).