(120 days)
Not Found
Not Found
No
The device is a standard examination glove and the summary focuses on material properties and performance standards, with no mention of AI or ML.
No
The device, an examination glove, is intended to prevent contamination and is not described as treating, preventing, or diagnosing any medical condition.
No
The device described is an examination glove, which is intended to prevent contamination between the examiner and the patient or substance handled, not to diagnose a condition.
No
The device description clearly states it is a physical examination glove, which is a hardware device. The performance studies and key metrics also relate to the physical properties and performance of the glove material.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use is to prevent contamination between the examiner and the patient or substance handled. This is a barrier function, not a diagnostic function performed in vitro (outside the body).
- Device Description: The description reinforces the barrier function of the glove.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body for the purpose of providing information for diagnosis, monitoring, or treatment. The performance studies focus on the physical properties and barrier integrity of the glove, not on its ability to detect or measure substances in a sample.
IVD devices are specifically designed to perform tests on biological samples (like blood, urine, tissue) to provide diagnostic information. This glove is a protective barrier.
N/A
Intended Use / Indications for Use
An examination glove is a disposable device intended for medical and examination purposes that is worn on the examiner's hand to prevent contamination between the examiner and the patient or substance handled
Product codes (comma separated list FDA assigned to the subject device)
LZA
Device Description
Class 1 Powderfree Nitrile Examination Gloves, coated with Allogel®, colored, 80LZA, that meets all the applicable requirements of ASTM D6319-2010 and FDA water leak test Powderfree Nitrile Examination Gloves coated with Allogel®, in colors Blue, Magenta or Copper, is a disposable device worn on the hand of a healthcare or similar personnel, to prevent contamination between the wearer of the glove and the person or substance handled
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hand
Indicated Patient Age Range
Not Found
Intended User / Care Setting
healthcare or similar personnel
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)
Performance data of gloves based on ASTM D6319 and FDA Watertight test
Key results:
- Watertight (1000ml) in accordance with ASTM D 5151: Pass G.I. AQL = 2.5
- Length (mm): 240 mm minimum for all sizes
- Palm Width (mm):
- XS: 75 - 80
- S: 83 - 84
- M: 94 - 96
- L: 107 - 109
- XL: 113 - 114
- Thickness (mm) (Single Layer):
- Finger: Min 0.12
- Palm: Min 0.10
- Cuff: Min 0.08
- Physical Properties In accordance with ASTM D 412:
- Before Aging:
- Tensile Strength (MPa): 18 - 31
- Ultimate Elongation (%): 530 - 600
- After Aging:
- Tensile Strength (MPa): 18 - 29
- Ultimate Elongation (%): 500 - 550
- Before Aging:
- Powder Content in accordance with ASTM D6124: Below 2 mg/glove
The performance data of the glove meets the requirements of ASTM D6319, including the Residual Powder requirement of max 2 mg per glove. The gloves meet ASTM D 6319 requirements for Dimensions and Tolerances and properties tested in accordance with ASTM D 412.
The Biocompatibility Tests consist of (1) Primary Skin Irritation Test and (2) Guinea Pig Sensitization (Buehler) test. The gloves have passed the Biocompatibility Test criteria of not being Sensitizers or Irritants.
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.
Not Found
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
110102
MAY 1 3 2011
PREVENTIVE CARE, INC.
510(k) SUMMARY
-
- Submitter: Preventive Care, Inc. 15215, Boulder Trail Rosemount, MN 55068, USA
-
- Contact Name: Anil Segat
-
- Phone: 651 322 9120
-
- Fax: 651 322 9196
- ട്. E Mail: anil@preventivecareinc.com
- January 1000, 2011 6. Date of Preparation:
-
- Device
,
| Trade Name: | Powderfree Nitrile Examination Gloves Coated with Allogel®, Blue, Magenta, Copper |
|---|---|
| Common Name: | Examination Glove |
| Classification name: | Patient Examination Glove (Class1) |
-
- Identification of legally marketed devices to which Equivalency is claimed:
- ರು. Intended use of device:
10. Summary of technological Characteristics compared to Predicate device:
Class 1 Powderfree Nitrile Examination Gloves, coated with Allogel®, colored, 80LZA, that meets all the applicable requirements of ASTM D6319-2010 and FDA water leak test Powderfree Nitrile Examination Gloves coated with Allogel®, in colors Blue, Magenta or Copper, is a disposable device worn on the hand of a healthcare or similar personnel, to prevent contamination between the wearer of the glove and the person or substance handled
There are no different technological characteristics compared to the predicate devices (detailed in Section 2 Form 3514) to which substantial equivalency is sought. They are all non sterile powderfree nitrile examination gloves (one coated with Allogel® Magenta color), with equivalent performance characteristics.
1
KI10102
11. Performance Data
Performance data of gloves based on ASTM D6319 and FDA Watertight test
| TEST | ASTM D6319
STANDARD
REQUIREMENT | POWDER FREE NITRILE EXAM
GLOVES COATED WITH
ALLOGEL® |
|-------------------------------------------------------------|------------------------------------------------|------------------------------------------------------------|
| | | RESULTS |
| 1. Watertight (1000ml) in
accordance with ASTM
D 5151 | Multiple Normal in
accordance with ISO 2859 | |
| | GI
AQL=2.5 | Pass GI
AQL = 2.5 |
| 2. Length (mm) | | |
| Size
XS | Min 220 | 240 mm minimum for all sizes |
| S | Min 220 | |
| M | Min 230 | |
| L | Min 230 | |
| XL | | |
| 3. Palm Width (mm) | | |
| Size
XS | 70 ± 10 | 75 - 80 |
| S | 80 ± 10 | 83 - 84 |
| M | 95 ± 10 | 94 - 96 |
| L | 110±10 | 107 - 109 |
| XL | 120±10 | 113 - 114 |
| 4. Thickness (mm)
(Single Layer) | | |
| Finger | Min 0.05 | Min 0.12 |
| Palm | Min 0.05 | Min 0.10 |
| Cuff | Min 0.05 | Min 0.08 |
| 5. Physical Properties
In accordance with
ASTM D 412 | | |
| Before Aging | Min 14 | 18 - 31 |
2
| Tensile Strength(MPa)
| Ultimate Elongation (%) | Min 500 | 530 - 600 |
|---|---|---|
| After Aging | ||
| Tensile Strength(MPa) | ||
| Ultimate Elongation (%) | Min 14 | |
| Min 400 | 18 - 29 | |
| 500 - 550 | ||
| 6. Powder Content in | ||
| accordance with ASTM | ||
| D6124 | Max 2.0mg/glove | Below 2 mg/glove |
- The performance data of the glove as shown above meets the requirements of ASTM D6319, A. • including the Residual Powder requirement of max 2 mg per glove. Data of an actual representative shipment is detailed in Section 14
- The performance data above show that the Powderfree Nitrile Examination Gloves coated with B. : Allogel®, meet ASTM D 6319 requirements for Dimensions and Tolerances. Data of an actual representative shipment is detailed in Section 14
- ্ The performance data above show that the gloves meet ASTM D 6319 requirements of properties tested in accordance with ASTM D 412. Data of an actual representative shipment is detailed in Section 14
- D. The Biocompatibility Tests consist of (1) Primary Skin Irritation Test and (2) Guinea Pig Sensitization (Buehler) test. The test reports are detailed in Sections 8&9 The gloves have passed the Biocompatibility Test criteria of not being Sensitizers or Irritants.
- 12. Conclusion
.
We concluded that the Multiple Private Labeled, Powderfree Nitrile Examination Gloves coated with Allogel® in colors Blue, Magenta or Copper meet the requirements of:
- ASTM D-6319 and FDA requirements for:
- ੋ Watertight test for pinholes
- ் Physical properties
- 0 Dimensions
- ্ Residual Powders
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol, with three curved lines representing the wings and body. The bird is positioned within a circular border, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
MAY 1 3 2011
Ms. Anil Segat President Preventive Care, Incorporated 15215 Boulder Trail Rosemount, Minnesota 55068
Re: K110102
Trade/Device Name: Powder-Free Nitrile Examination Gloves Coated with AlloGel® (Blue/Magenta/Copper) Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: March 18, 2011 Received: March 24, 2011
Dear Ms. 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.
4
Page 2- Ms. 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 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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
hn for
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 Form
510(k) Number (if known): K110102
Device Name: : Powder-Free Nitrile Examination Gloves Coated with AlloGel® (Blue/Magenta/Copper)
Indications for Use:
An examination glove is a disposable device intended for medical and examination purposes that is worn on the examiner's hand to prevent contamination between the examiner and the patient or substance handled
Prescription Use _____________________________________________________________________________________________________________________________________________________________
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)
Ellyabeth A. Clamitz Will
(ivision Sign-Off)
of Anesthesiology, General Hospital fection Control, Dental Devi
Page 1 of __ 1
510(k) Number: K110102