(151 days)
Not Found
No
The device is a simple examination glove and the summary contains no mention of AI, ML, or any related technologies.
No.
The device is a patient examination glove, intended for preventing contamination, not for treating a disease or condition.
No
The device is a patient examination glove, intended to prevent contamination. It does not perform any diagnostic function.
No
The device is a physical examination glove made of polyethylene material. The description and testing focus on the physical properties and performance of the glove, 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: The description details the material, form, and sizes of a glove. It does not describe any components or processes related to analyzing biological samples.
- Performance Studies: The performance studies focus on physical properties (strength, leakage, powder content) and biocompatibility, which are relevant to a physical barrier device, not a diagnostic test.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information about a patient's health status.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device does not fit that description.
N/A
Intended Use / Indications for Use
A powder-free, non-sterile patient 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.
Product codes
LZA
Device Description
Patient Examination glove - Disposable- Single use only - Non-sterile\
- The C2 Powder Free Polyethylene Examination Gloves are made of translucent (clear), . Low Density Polyethylene material and are powder free. The C2 Powder Free Polyethylene Examination Gloves come in five sizes: Small, Medium, Large, X Large and XX Large. The gloves are loose fitting.
The AmerCare C2 Powder Free Polyethylene Examination Glove meets all current + specifications under ASTM 5250-06 Standard Specification for Poly (vinyl chloride) Gloves for Medical Application.
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)
- Physical Testing per ASTM 5250-06 Standard Specification for Poly (vinyl chloride) . gloves for medical application
- Powder Free Per ASTM 6124-06 Procedure 1: Residual Powder is 0.18mg -
- Water Leakage Testing per US 21CFR 800.20
- Biocompatibility Testing per ISO 10993-1, 10993-5 and 10993-10 .
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
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510(k) Summary for AmerCare C2 Powder Free Polyethylene Examination Glove
1. Submission Sponsor
AmerCare Inc. 7450 Industry Drive N. Charleston, SC 29418 United States Phone: 843-824-0550 Fax: 843-825-2550 Contact: Ty King, President and CEO FDA Establishment Registration #: 1053331
2. Submission Correspondent
AmerCare Inc. 7450 Industry Drive N. Charleston, SC 29418 United States Phone: 843-824-0550 Fax: 843-825-2550 Contact: Ty King, President and CEO FDA Establishment Registration #: 1053331
3. Date Prepared
Summary Prepared: April 5tt, 2012
4. Device Name
Trade/Proprietary Name: C2 Powder Free Polyethylene Examination Glove Common/Usual Name: Patient Examination Glove Classification Name: Patient Examination Glove Classification Regulation: 880.6250 Classification Panel: 880 General Hospital Product Code: LZA Device Class: 1
Predicate Device
K110944 Non-sterile Powder Free Vinyl Patient Examination Gloves Clear (non)colored
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5. Device Description
Patient Examination glove - Disposable- Single use only - Non-sterile
- The C2 Powder Free Polyethylene Examination Gloves are made of translucent (clear), . Low Density Polyethylene material and are powder free. The C2 Powder Free Polyethylene Examination Gloves come in five sizes: Small, Medium, Large, X Large and XX Large. The gloves are loose fitting.
| Physical Dimensions | C2 Powder Free Polyethylene
Examination Gloves | FDA Recognized consensus
standard ASTM D 5250-06 |
|---------------------|---------------------------------------------------|-----------------------------------------------------|
| Overall Length: | $255 \pm 5$ mm | 230 mm minimum |
| Width: | $105 \pm 5$ mm (for large glove) | $105 \pm 5$ mm (for large glove) |
| Palm thickness: | .08mm minimum | .08mm minimum |
| Finger thickness: | .05mm minimum | .05mm minimum |
| Tensile Strength | | |
| Before Aging | 11 MPa minimum | 11 MPa minimum |
| After Aging | 11 MPa minimum | 11 MPa minimum |
| Ultimate Elongation | | |
| Before Aging | 300% minimum | 300% minimum |
| After Aging | 300% minimum | 300% minimum |
| Pinhole AQL | 2.5 | 2.5 |
The AmerCare C2 Powder Free Polyethylene Examination Glove meets all current + specifications under ASTM 5250-06 Standard Specification for Poly (vinyl chloride) Gloves for Medical Application.
6. Intended Use
A powder-free, non-sterile patient 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 and Substantial Equivalence
AmerCare Inc. believes that the C2 Powder Free Polyethylene Examination Gloves, 510(k) number K113639, are substantially equivalent to the predicate gloves manufactured by Wanga Plastic Co. Ltd., Powder Free Vinyl Examination Glove, 510(k) Number K110944. The proposed device and predicate device use a similar plastic flexible barrier film to achieve a device for the intended use.
2
The properties of the C2 Powder Free Polyethylene Examination Glove and Wanga Plastic Co. Ltd., Powder Free Vinyl Examination Glove are compared in the following table. [The header repeats on each page.]
| Manufacturer | AmerCare Inc.
Proposed Glove | Wanga Plastic Co. Ltd.
Predicate Glove | Proposed Glove
Compared To Wanga
Predicate Glove |
|--------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------|
| Trade name | C2 Powder Free Poly-
ethylene Examination
Glove | Powder Free Vinyl
Examination Glove | Comparable |
| 510(k) number | K113639 | K110944 | |
| Product code | LZA | LYZ | Comparable |
| Regulation # | 880.6250 | 880.6250 | Same |
| Regulation name | Patient Examination
Glove | Patient Examination
Glove | Same |
| Indication for use | A powder-free, non-
sterile patient
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. | Non-sterile powder free
vinyl patient examination
glove, Clear (noncolored)
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. | Comparable |
| Barrier Film
Material | Polyethylene | Vinyl | Comparable synthetic
polymer flexible barrier
films |
| Color | Translucent [clear] | Translucent [clear] | Same |
| Biocompatible | Not a Primary Skin
Irritant;
Not a Dermal Sensitizer | Not a Primary Skin
Irritation; Not a Dermal
sensitization | Same |
| Powder-free | Powder-free per FDA
recognized ASTM
D6124-06 | Powder-free per FDA rec-
ognized ASTM D6124-06 | Same |
| Physical
properties | Per FDA recognized
ASTM D 5250-06 | Per FDA recognized
ASTM D 5250-06 | Same |
| Freedom from
Pinholes | Yes,
per FDA 21 CFR 800.20 | Yes,
Per FDA 21 CFR 800.20 | Same |
| Sizes | S, M, L, XL and XXL | S, M, L and XL | Comparable |
The C2 Powder Free Polyethylene Examination-Glove-from-AmerCare-Inc., shares the same or comparable indications for use, device operation, biocompatibility, freedom from pinholes, and functional capabilities; therefore, it is substantially equivalent to the predicate device.
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8. Non-Clinical Testing
-
Physical Testing per ASTM 5250-06 Standard Specification for Poly (vinyl chloride) . gloves for medical application
113639 -
Powder Free Per ASTM 6124-06 Procedure 1: Residual Powder is 0.18mg -�
-
Water Leakage Testing per US 21CFR 800.20 ●
-
Biocompatibility Testing per ISO 10993-1, 10993-5 and 10993-10 .
9. Clinical Testing
There was no clinical testing required to support the medical device as the indications for use is equivalent to the predicate device. The substantial equivalence of the device is supported by the non-clinical testing.
10. Conclusion
By definition, a device is substantially equivalent to a predicate device when the device has the same intended use and the same technological characteristics as the previously cleared predicate device. Or the device has the same intended use and different technological characteristics that can be demonstrated that the device is substantially equivalent to the predicate device, and that the new device does not raise different questions regarding its safety and effectiveness as compared to the predicate device.
It has been shown in this 510(k) submission that the differences between the AmerCare C2 Powder Free Polyethylene Examination Glove and the Wanga Plastic Co. Ltd., predicate glove do not raise any questions regarding its safety and effectiveness. The C2 Powder Free Polyethylene Examination Gloves, as designed and manufactured to yield a safe and effective barrier device, are determined to be substantially equivalent to the referenced predicate device.
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4
Image /page/4/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the seal is a stylized image of an eagle with three lines representing its wings.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
MAY - 8 2012
Mr. Ty King President and CEO AmerCare Inc. 7450 Industry Drive N. Charleston, South Carolina 29418
Re: K113639
Trade/Device Name: C2 Powder Free Polyethylene Examination Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: 1 Product Code: LZA Dated: March 28, 2012 Received: April 20, 2012
Dear Mr. King:
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 Eederal Register.
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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,
Anthony O. Arica
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
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Indications for Use
510(k) Number (if known): K113639
Device Name: C2 Powder Free Polyethylene Examination Gloves
Indications For Use: A powder-free, non-sterile patient 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.
Prescription Use Over-The-Counter Use YES AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODB)
E.L.H.R. Ulam-William
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K113639
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