(422 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 document describes examination gloves, which are used for barrier protection and contamination prevention, not for treating or preventing a disease or condition.
No
Explanation: The device is described as "Examination Gloves" intended to prevent contamination between patient and examiner. There is no mention of it being used to diagnose a medical condition or disease.
No
The device description explicitly states it is a physical product (gloves made of natural latex rubber) and does not mention any software components.
No, 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 barrier function, not a diagnostic test performed on a sample from the body.
- Device Description: The device is described as "Patient Examination Gloves" and falls under the product code for "Powder Free Latex Examination Gloves". This classification is for medical devices used as a physical barrier.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening
The information provided clearly indicates that this device is a medical glove used for protection and contamination prevention, not for performing diagnostic tests.
N/A
Intended Use / Indications for Use
Palm Pro X - Powder Free Latex Examination Gloves (6PF2G30) 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.
Product codes
LYY
Device Description
The gloves are made of natural latex rubber and are worn on the examiner's hand to prevent contamination between patient and examiner.
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)
Clinical data is not needed for gloves or for most devices cleared by the 510(k) process.
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
005 510(k) Summary as required by 21CFR807.92(c).
1.0 Submitter:
Name : Dipped Products Limited Street Address : 400 Deans Road City : Colombo 10 Country: Sri Lanka Contact Person: Dr. W.S.E.F. Fernando Phone No. +94 11 2683964 FAX No. +94 11 2699018 Registration Number: 8040667 Date Summary Prepared: 1-4-2010
2.0 Name of the device:
Proprietary or Trade Name: Palm Pro X - Powder Free Latex Examination Gloves (6PF2G30) Common Name : Patient Examination Gloves, Powder Free (21 CFR 880.6250) Product Class: I Device Name: Powder Free Latex Examination Gloves, Non-Sterile with Protein Content Labeling Claim (50 Micrograms or less)
3.0 Identification of the Predicate Device(s):
Classification Name : Patient Examination Gloves (21 CFR 880.6250) Product Class: I Product Code: 80 LYY (Powder Free Latex Examination Gloves, Non Sterile with Protein Content Labeling Claim (50 Micrograms or less) meets all the requirements of ASTM standard D 3578 - 05 .) for type I gloves
Identification of current legally marketed predicate devices
| Manufacturer | Product Description |
|---|---|
| Predicate 1 | |
| WRP | |
| 510(k) Number: K022808 | Dermagrip Powder Free Latex |
| Examination Gloves | |
| Predicate 2 | |
| Maytex Corporation | |
| 510(k) Number: K935315 | Maytex Powder-Free Latex Exam |
| Gloves |
4.0 Description of the Device:
Patient Examination Gloves (21 CFR 880.6250)
Product Class: I
Product Code: 80 LYY (Powder Free Latex Examination Gloves, Non Sterile with Protein Content Labeling Claim (50 Micrograms or less) meets all the requirements of ASTM standard D 3578-05.). The gloves are made of natural latex rubber and are worn on the examiner's hand to prevent contamination between patient and examiner.
1
5.0 Intended Use of the Device:
Palm Pro X - Powder Free Latex Examination Gloves (6PF2G30) 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.
6.0 Technical Characteristics of device compared to the legally marketed predicate devices
| Dimension Characteristics: | ||||||||
|---|---|---|---|---|---|---|---|---|
| Sample Ref | thickness (mm) | Palm_width (mm) | Length (mm) | |||||
| Finger | palm | XS | S | M | L | XL | ||
| Palm Pro X - | ||||||||
| Powder Free Latex | ||||||||
| Examination | ||||||||
| Gloves (6PF2G30) | 0.37 | |||||||
| ±0.03 | 0.30 min | 77 | 85 | 95 | 110 | 118 | 300 min | |
| WRP | ||||||||
| 510(k) | ||||||||
| K022808 | 0.40 | 0.30 | 79 | 84 | 96 | 105 | 117 | 292 |
| Maytex | ||||||||
| 510(k) | ||||||||
| K935315 | 0.40- | |||||||
| 0.46 | 0.38- | |||||||
| 0.44 | N/S | N/S | 98- | |||||
| 103 | 103- | |||||||
| 110 | 111- | |||||||
| 117 | 300 min | |||||||
| ASTM | ||||||||
| D3578-05 | 0.08 | |||||||
| min | 0.08 | |||||||
| min | 70 ±10 | 80 ±10 | 95 ± 10 | 111± | ||||
| 10 mm | N/S | 220/230 min |
Dimension Characteristics :
2
| Sample Ref | Tensile strength
(MPa) | | Elongation at break
( Percebnt) | | EP content |
|----------------------------------------------------------------------|---------------------------|----------------------|------------------------------------|----------------------|-------------------------------|
| | unaged | Aged
(70C/166hrs) | unaged | Aged
(70C/166hrs) | |
| Palm Pro X - Powder
Free Latex
Examination Gloves
(6PF2G30) | 21 min | 16 min | 750 min | 600 min | 50µg/g or less |
| WRP
510(k)
K022808 | 29 | 26 | 900 | 860 | 50µg/g or less |
| Maytex
510(k)
K935315 | 14 min | 14 min | 500 min | 500 min | Less than 100µg/g of
glove |
| ASTM D3578-05 | 18 min | 14 min | 650 min | 500 min | 200 µg /dm² |
Performance Characteristics (Mechanical Performance, Extractable Protein Content :
NOTE: The term "min" refers to "minimum" in these tables.
7.0 Substantial Equivalence Based on Assessment of Clinical Performance Data:
Clinical data is not needed for gloves or for most devices cleared by the 510(k) process.
8.0 Conclusions:
The subject device has the same intended use and similar characteristics as the predicate device(s). Technical characteristics and performance of the subject device are comparable to those of the predicate device(s). Therefore no new questions of safety or effectiveness due to performance are raised. Similarly, biocompatibility documentation demonstrates that materials used to fabricate the subject device do not raise any new questions of safety or effectiveness. Thus, the Dipped Palm Pro X - Powder Free Latex Examination Gloves (6PF2G30) is substantially equivalent to the predicate device(s).
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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 with three overlapping wings, representing the department's commitment to health, well-being, and human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring. MD 20993-0002
Dipped Products Limited C/O Mr. Bhavesh V. Sheth Responsible Third Party Official Intertek Testing Services 2307 East Aurora Road, Unit B7 Twinsburg, Ohio 44087
MAY 2 7 2011
Re: K100895
Trade/Device Name: Palm Pro X –Powder Free Latex Examination Gloves (6PF2G30) Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYY Dated: May 13, 2011 Received: May 16, 2011
Dear Mr. Sheth:
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.
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Page 2- Mr. Sheth
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 (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 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 vours.
Susan Kunna
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
510(k) Number : K100895
Device Name: Palm Pro X - Powder Free Latex Examination Gloves (6PF2G30).
Indications for Use:
Palm Pro X - Powder Free Latex Examination Gloves (6PF2G30) 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.
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use AND/OR (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)
Elizabet D. Querio-Willis
Division Sign-Off) :)ivision of Anesthesiology, General Hospital Infection Control, Dental Devices
100895 510(k) Number: