(156 days)
No
The device description and performance metrics are solely related to the physical properties and barrier function of a powdered examination glove, with no mention of AI or ML.
No.
A patient examination glove is intended to provide a barrier against contaminants, not to treat or prevent a disease or condition.
No
The device, a patient examination glove, is intended to provide a barrier against contaminants and infectious materials, not to diagnose any condition or disease.
No
The device is a physical glove, not software. The description clearly outlines physical characteristics and performance metrics related to a tangible product.
Based on the provided information, 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 to be worn on the hand or finger(s) for medical purposes to provide a barrier against potentially infectious materials and other contaminants." This describes a physical barrier device used for protection during medical procedures.
- Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The description of this device and its intended use does not involve the examination of such specimens.
- Device Description: The description focuses on the physical characteristics and materials of a glove.
- Performance Studies and Metrics: The performance studies and metrics listed relate to the physical properties and integrity of the glove (length, width, thickness, tensile strength, elongation, pinhole AQL), not diagnostic performance related to analyzing biological samples.
Therefore, this device falls under the category of a medical device used for barrier protection, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
A powdered Patient Examination Glove is a disposable device made of natural rubber latex or symthetic material that bears powder to facilitate donning and is intended to be worn on the hand or finger(s) for medical purposes to provide a barrier against potentially infectious materials and other contaminants.
Product codes
LYY
Device Description
Patient Examination Glove, Powdered (with protein labeling claims claims 300 micrograms or less)
Overall Length: 230 mm minimum
Width: 95 mm minimum (for medium Glove)
Palm Thickness: 0.08 mm minimum
Finger Thickness: 0.08 mm minimum
Tensile Strength: 18 MPa minimum (before aging), 14 MPa minimum (after aging)
Ultimate Elongation: 650% minimum (before aging), 500% minimum (after aging)
Pinhole AQL: 2.5 (@70C for 7 days)
The data for this examination glove meets all of the current specification listed under ASTM Standard Specification D3578-05
These gloves are not claimed to be for Specialty or Chemotherapy use.
No Former Release Powder or Chemical used.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hand or finger(s)
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)
Not Found
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
AUG - 7 2008
510(K) Summary (K08606) Powdered Latex Patient Examination Glove with Protein Label Claims (300 Micrograms or less)
Name Alatech Healthcare LLC 1600, State Docks Rd, Eufaula Alabama 36027 U.S.A. Phone Number (334) 688-8520
Registration Number 3005627398
Activity of Applicant Manufacturer
Contact Person at Firm Neil Anderson RAC
(334) 688- 8520 Phone Number
Email raexprt@yahoo.com
Truthful and Accurate Statement
Indications for Use
Name and Location of Actual Manufacturer
Alatech healthcare LLC 1600, State Docks Road Eufaula Alabama 36027 USA
Phone Number (334) 688-8520
Label, Labeling and Advertising
Fax (334) 688- 8521
Fax (334) 688-8521
See Appendix 1
See Appendix II
Fax (334) 688-8521
See Appendix III
1
Device Classification
Class 1
Substantial Equivalence device Description
Patient Examination Glove, Powdered (with protein labeling claims claims 300 micrograms or less) Predicate device K050527 Powdered Latex Examination Glove with Protein Labeling Claim, ( 300 micrograms or less) Manufacturer-SPI Gloves, 5 Persiaran Greentown 8, Greentown Business Center, 39450 Ipoh, Perak, Darul Ridzuan, MALAYSIA
Product Code Latex 80-LYY
Specifications
Overall Length
230 mm minimum
Width
Palm Thickness
Finger Thickness
Tensile Strength
Tensile Strength
Ultimate Elongation
Ultimate Elongation
Pinhole AQL
95 mm minimum (for medium Glove)
0.08 mm minimum
0.08 mm minimum
18 MPa minimum (before aging)
14 MPa minimum (after aging)
650% minimum (before aging)
500% minimum (after aging)
2.5 (@70C for 7 days)
The data for this examination glove meets all of the current specification listed under ASTM Standard Specification D3578-05
Specialty, Chemotherapy Gloves
These gloves are not claimed to be for Specialty or Chemotherapy use.
Former Release Powder or Chemical
None used.
2
Image /page/2/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-like symbol with three distinct, curved lines forming its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" arranged in a circular fashion around the emblem.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Neil Anderson R.A.C Manager of Regulatory Affairs Alatech Healthcare, LLC 1600 State Docks Road Eufaula, Alabama 36027
AUG - 7 2008
Re: K080606
Trade/Device Name: Powdered Latex Patient Examination Glove with Protein Label Claims (300 micrograms or less) Regulation Number: 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYY Dated: July 11, 2008 Received: July 21, 2008
Dear Mr. Anderson:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
3
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complics 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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801). please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Mannels Lend, n.d. for 11
Chiu Lin. Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Appendix II
Indications for Use
Alatech Healthcare LLC Applicant Name K080606 510(k) Number Powdered Latex Patient Examination Glove with Device Name Protein Label Claims (300 micrograms or less)
A powdered Patient Examination Glove is a disposable device made of natural rubber latex or symthetic material that bears powder to facilitate donning and is intended to be worn on the hand or finger(s) for medical purposes to provide a barrier against potentially infectious materials and other contaminants.
Prescription use (21CFR 801 subpart D) Over the Counter (21CFR. subpart C
Concurrence of CDRH Office of Device Evaluation
Shiela A Murphy, MD
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K080616