(134 days)
Not Found
No
The device is a simple examination glove and the summary contains no mention of AI or ML.
No
The device is described as an examination glove intended to prevent contamination between a patient and examiner, acting as a barrier. It does not provide any therapeutic function like treating, diagnosing, or mitigating a disease.
No
Explanation: The device is an examination glove, which acts as a barrier to prevent contamination between the examiner and the patient. It is not intended to diagnose medical conditions or provide diagnostic information.
No
The device description clearly states it is a glove made from natural rubber, which is a physical hardware component. The summary focuses on the physical properties and performance of the glove as a barrier.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device 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 examiner." This describes a barrier device for physical protection, not a device used to examine specimens derived from the human body for diagnostic purposes.
- Device Description: The description reinforces the function as a physical barrier (glove).
- Lack of IVD Characteristics: The description and performance metrics focus on physical properties, barrier function, and biocompatibility. There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information.
- Predicate Device: The predicate device is also an examination glove, further indicating the device's classification as a general medical device, not an IVD.
IVD devices are specifically designed to perform tests on samples like blood, urine, tissue, etc., to diagnose diseases or conditions. This examination glove does not perform such tests.
N/A
Intended Use / Indications for Use
An Examination glove 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 examiner.
Product codes
LYY
Device Description
The device is a glove with five fingers made from natural rubber that covers the hand on both sides up to the wrist, using a dip technology manufacturing process. The gloves are ambidextrous and therefore can be donned on either hand. The gloves are non sterile and for single use only, to be discarded after each examination is complete. The glove acts as a barrier between the examiner and the subject being examined in order to prevent contamination between the examiner and the subject. The physical properties of the glove are identified in paragraph 9 below, as compared to those required by ASTM D 3578 version 2010.
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
examiner
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 device meets all the applicable technical requirements of ASTM D3578 Version 2010 for standard specifications for rubber examination gloves, ASTM D5712 Version 2010 for analysis of aqueous extractable protein, ASTM D6124 Version 2006 for residual powder, ASTM D412 Version 06ae2 for vulcanized rubber and thermoplastic elastomers-tension, ASTM D5151 Version 2006 for detection of holes, and ISO 10993 Version 2010 for biological evaluation (skin irritation and sensitization).
Physical properties such as length, palm width, thickness (finger, palm, cuff), tensile strength (before and after aging), ultimate elongation (before and after aging), powder content, and residual latex proteins were evaluated against ASTM standards. The device showed results within or exceeding the standard requirements. For example, tensile strength before aging was 18 - 31 MPa (Min 14 required), ultimate elongation before aging was 530 - 600% (Min 500 required), and powder content was below 2.0 mg/glove (Max 2.0 required). The device passed biocompatibility tests, not being sensitizers or irritants.
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
PREVENTIVE CARE, INC.
510 (k) SUMMARY
DATE: June 10th, 2013
1. Submitter
Preventive Care, Inc. 15215, Boulder Trail Rosemount, MN 55068 Tel: 651 322 9120 Fax: 651 322 9196 E Mail: anil@preventivecareinc.com JUL 2 4 2013
2. Contact Person
Contact: Anil Segat Tel: 651 322 9120 Fax: 651 322 9196 E Mail: anil@preventivecareinc.com
3. Name of device
Trade name: Exam Perfect Powderfree Latex Examination Gloves Coated with Allogel® Common Name: Exam Gloves Classification Name: Patient Examination Glove Classification Number: Class 1 Regulation Number: 21 CFR 880.6250 Product code: LYY
4. Legally Marketed Device to which equivalency is claimed: K110102
Powderfree Nitrile Examination Gloves Coated with Allogel®, LZA, Class 1, that meets or exceeds all the applicable requirements of ASTM standards and FDA water leak test.
5. Device Description
The device is a glove with five fingers made from natural rubber that covers the hand on both sides up to the wrist, using a dip technology manufacturing process. The gloves are ambidextrous and therefore can be donned on either hand. The gloves are non sterile and for single use only, to be discarded after each examination is complete. The glove acts as a barrier between the examiner and the subject being examined in order to prevent contamination between the examiner and the subject. The physical properties of the glove are identified in paragraph 9 below, as compared to those required by ASTM D 3578 version 2010.
1
6. Intended use of the Device
An Examination glove 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 examiner.
7. Summary of the technological characteristics of the Device
The device meets all the applicable technical requirements of :
| ASTM D3578
Version 2010 | Standard specifications for rubber examination gloves. Data of an actual representative
shipment is detailed in Section 14 (original submission). | | ASTM D3578 -2010
STANDARD REQUIREMENT | POWDER FREE LATEX EXAM
GLOVES COATED WITH ALLOGEL®
RESULTS |
|----------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------|------------------------------------------------------------------|
| ASTM D5712
Version 2010 | Standard test method for analysis of aqueous extractable protein in natural rubber and
its products using the modified lowry method. Data of an actual representative
shipment is detailed in Section 14 (original submission). | 1. Watertight (1000ml)
In accordance with ASTM D5151 | Multiple Normal
In accordance with ISO 2859
Version 10-2006
GI AQL2.5 | Pass G1 AQL 2.5 |
| ASTM D6124
Version 2006 | Standard test method for residual powder on medical gloves. Data of an actual
representative shipment is detailed in Section 14 (original submission). | 2. Length (mm)
Size XS
S
M
L
XL | Min 220
Min 220
Min 230
Min 230
Min 230 | 240 mm minimum for all sizes |
| ASTM D412
Version 06ae2 | Test method for vulcanized rubber and thermoplastic rubbers and thermoplastic
elastomers-tension. Data of an actual representative shipment is detailed in Section 14
(original submission). | 3. Palm Width (mm)
Size XS
S
M
L
XL | 70 ± 10
80 ± 10
95 ± 10
110 ± 10
120 ± 10 | 75 - 80
83 - 84
94 - 96
107-109
113-114 |
| ASTM D5151
Version 2006 | Standard test method for detection of holes in medical gloves. Data of an actual
representative shipment is detailed in Section 14 (original submission). | 4. Thickness (mm)
(Single Layer)
Finger
Palm
Cuff | Min 0.05
Min 0.05
Min 0.05 | Min 0.12
Min 0.10
Min 0.08 |
| ISO 10993
Version 2010 | Biological evaluation of medical devices Part 10, tests for skin irritation and
sensitization. The test reports are detailed in section 8 & 9 (original submission). The
gloves have passed the biocompatibility test criteria for not being sensitizers or irritants. | 5. Physical Properties
In accordance with ASTM D 412
Before Aging
Tensile Strength(MPa)
Ultimate Elongation (%)
After Aging
Tensile Strength(MPa)
Ultimate Elongation (%) | Min 14
Min 500
Min 14
Min 400 | 18 - 31
530 - 600
18-29
500-550 |
| 6. Powder Content
In accordance with ASTM D6124 | Max 2.0mg/glove | Below 2.0mg/glove | | |
| 7. Residual Latex Proteins | Max 200 micro grams/dm2 | Max 200 micro grams/dm2 | | |
The above are the principal technical standards that the device needs to comply with. The device has substantially enhanced physical properties as compared to those required by ASTM and other relevant standards.
8. Substantial Equivalence
The substantial equivalence to the predicate device is based on non clinical assessment data. A comparison was made of the physical properties and characteristics of both devices for the following attributes, which were found to be substantially similar:
- a. A glove made from natural or synthetic rubber
- b. Use and description
c. Physical properties such as, length, width, thickness, tensile strength, freedom from holes, and residual powder. Although the predicate device made from synthetic rubber has no residual natural rubber proteins, the applicant device made of natural rubber complies with the requirements of ASTM D3578 for the maximum allowable residual proteins. The tensile strength and elongation of the applicant device was found to be superior. The thickness of the applicant device was marginally more than the predicate device, but this is normal for latex examination gloves used for medical purposes and it is within the tolerance levels for such devices.
d. Inner coating made from Allogel®
2
9. Physical Performance data
3
10. Substantial equivalence comparison table
| APPLICANT | PREDICATE (K110102) | |
|---|---|---|
| PATIENT EXAMINATION | ||
| GLOVE | PATIENT EXAMINATION | |
| GLOVE | ||
| INICATIONS OF USE | ||
| AMBIDEXTROUS | YES | YES |
| OVER THE COUNTER USE | YES | YES |
| SINGLE USE | YES | YES |
| NON STERILE | YES | YES |
| POWDERFREE | YES | YES |
| POSITIVE BIOCOMPATABILITY TEST RESULTS | NON IRRITANT | |
| NON SENSITIZER | NON IRRITANT | |
| NON SENSITIZER | ||
| PRIMARY RAW MATERIAL | NATURAL RUBBER | SYNTHETIC NITRILE RUBBER |
| COATED WITH ALLOGEL® | YES | YES |
| ALLOGEL® FORMULATION AND PROCESS, | ||
| CONTROLLED BY PREVENTIVE CARE, INC. | YES | YES |
| PRIMARY LABEL | ALLOGEL®POWDERFREE | |
| LATEX EXAMINATION GLOVES | ALLOGEL®POWDERFREE | |
| NITRILE EXAMINATION | ||
| GLOVES | ||
| SPECIFICATIONS AND PERFORMANCE | ||
| TENSILE STRENGTH BEFORE AGING MINIMUM | 18 MPA | 14 MPA |
| APPLICANT PERFORMANCE (see VOL_014_001) | 18 MPA | |
| AFTER AGING AT 70 DEG C 7 DAYS. MINIMUM | 14 MPA | 14 MPA |
| APPLICANT PERFORMANCE (see VOL_014_001) | 17 MPA | |
| ULTIMATE ELONGATION BEFORE AGING MIN. | 650% | 500% |
| APPLICANT PERFORMANCE (see VOL_014_001) | 797% | |
| AFTER AGING AT 70 DEG C 7 DAYS. MINIMUM | 500% | 400% |
| APPLICANT PERFORMANCE (see VOL_014_001) | 753% | |
| WIDTH AT PALM (MEDIUM) +/- 5 MM | 95 MM | 95 MM |
| APPLICANT PERFORMANCE (see VOL_014_001) | 98 MM | |
| LENGTH (MEDIUM) +/- 5 MM | 245 | 245 MM |
| APPLICANT PERFORMANCE (see VOL_014_001) | 241 MM | |
| THICKNESS AT PALM MINIMUM | 0.08 MM | 0.07 MM |
| APPLICANT PERFORMANCE (see VOL_014_001) | 0.11 MM | |
| THICKNESS AT FINGER MINIMUM | 0.08 MM | 0.07 MM |
| APPLICANT PERFORMANCE (see VOL_014_001) | 0.13 MM | |
| THICKNESS AT CUFF MINIMUM | 0.08 MM | 0.07 MM |
| APPLICANT PERFORMANCE (see VOL_014_001) | 0.08 MM | |
| DETECTION OF PIN HOLES (ASTM D5151) | AQL 2.5 MAX | AQL 2.5 MAX |
| APPLICANT PERFORMANCE (see VOL_014_001) | AQL 1.5 | |
| RESIDUAL POWDER | 2 MG/GLOVE | 2 MG/GLOVE |
| APPLICANT PERFORMANCE (see VOL_014_001) | 0.58 MG/GLOVE (MEDIUM) | |
| MINIMUM SHELF LIFE | 3 YEARS | 3 YEARS |
4
| MANUFACTURING PROCESS | ||
|---|---|---|
| CONTINUOUS LINKED CHAIN DIP TECHNOLOGY | YES | YES |
| ALLOGEL ® DIP PROCESS | YES | YES |
| PRINCIPAL MATERIALS USED IN THE DIP | ||
| PROCESS FOR CLEANING, COAGULATING, | ||
| HEATING AND DRYING ARE THE SAME | YES | YES |
11. Substantial equivalence summary discussion & conclusion
The gloves covered by this application are deemed to be substantially equivalent to the predicate, K110102, Powderfree Nitrile Examination gloves coated with Allogel®. Comparisons between the applicant and this predicate device indicate substantial equivalence, in that both:
-
- Have the same indication of use
-
- Are Powderfree Patient Examination Gloves
-
- Do not show any adverse results in bio compatibility tests
-
- Are non sterile and are sold over the counter
-
- Are coated with Allogel® on the inside
-
- Have similar performance specifications and physical properties
-
- Meet pin hole AQL requirements as per ASTM D5151 version 2006
-
- Are ambidextrous
- Are manufactured using a continuous linked chain dip technology with the usage of similar chemicals
-
- Use a primary raw material that has properties of Rubber (natural/synthetic)
-
- Have similar shelf life
The data and explanations provided above, both for the applicate device, illustrates that there are no substantial differences in the use, physical properties and characteristics of the devices. We can therefore conclude that the two devices are substantially equivalent. The applicant devise is therefore as safe, as effective and performs as well as, or better than the predicate device.
5
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/5/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle or bird-like symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular fashion around the symbol.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 24, 2013
Preventive Care, Incorporated Mr. Anil Segat President 15215 Boulder Trail ROSEMOUNT MN 55068
Re: K130667
Trade/Device Name: Powder- Free Latex Examination Glove Coated with AlloGel® Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: 1 Product Code: LYY Dated: April 24, 2013 Received: April 25, 2013
Dear Mr. Segat:
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.
6
Page 2 - Mr. Segat
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 contact the Division of Small Manufacturers. International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industrv/default.htm. 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/Safetw/ReportalProblem/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/Resources/orYou/Industry/default.htm.
Sincerely yours.
DAGRID
Tejashri Purohit-Sheth, M.D. Clinical Deputy Director
FOR
Kwame Ulmer M.S. Acting Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
7
Indications for Use Form
510(k) Number (if known): K130667
Device Name: : Powder-Free Latex Examination Gloves Coated with AlloGel®
Indications for Use:
An Examination glove 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 examiner.
Prescription Use _ _ _ _ _ _ AND/OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(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 (ODE)
Sreekanth Gutala -S 2013.07.22 14:24:51 =04'00'
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
Page 1 of ____________________________________________________________________________________________________________________________________________________________________
510(k) Number: ماما 30(k) Number