(71 days)
Not Found
No
The device description and performance studies focus on the physical properties and biocompatibility of a medical glove, with no mention of AI or ML.
No.
The device is described as a medical glove for contamination prevention, not for treating a disease or condition.
No
Explanation: The device is described as a medical glove intended to prevent contamination, not to diagnose any condition or disease.
No
The device is a physical medical glove made of nitrile, not a software application. The description focuses on material properties, sterilization, and physical performance testing.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as a "medical glove to be worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patient." This describes a barrier device used externally, not a device used to examine specimens derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of disease or impairment.
- Device Description: The description details a "Class I sterile nitrile examination glove." This aligns with a medical device used for protection and examination, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information. The performance studies focus on biocompatibility and viral penetration, which are relevant to the barrier function of a glove, not diagnostic capabilities.
Therefore, this device is a medical glove, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
This is a medical glove to be worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patient.
Product codes (comma separated list FDA assigned to the subject device)
LZA
Device Description
Class I sterile nitrile examination glove, powder free and meeting all requirements of ASTM D3578-99, ASTM 6124-97, and ISO 11137, Part 2, Sterilization of Health Care Products.
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
health care and 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)
Not Found
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.
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
Ko62138
Image /page/0/Picture/1 description: The image shows the logo for Mölnlycke Health Care. The logo consists of a cluster of five circles on the left side, resembling a paw print or a flower. To the right of the circles, the text "MÖLNLYCKE HEALTH CARE" is written in two lines. The text is in a simple, sans-serif font.
MoInlycke Heath Care US, LLC 5550 Peachtree Parkway, Suite 500 Norcross, GA. 30092 Sterile Powder Free, Blue Nitrile Examination Glove 510(k)
OCT - 5 2006
ATTACHMENT VIIII - 510(k) SUMMARY
| Applicant: | Mölnlycke Health Care US, LLC
5550 Peachtree Parkway Suite 500
Norcross, GA 30092 | | |
|--------------------|-------------------------------------------------------------------------------------------|-----------------------------------------------------------|--|
| Contact Person: | Steven Dowdley, Director of Regulatory Affairs
Tel.: 678-250-7930
Fax: 678-250-7986 | | |
| Device Name: | Proprietary Name: | BioExam Powder Free,
Sterile Nitrile Examination Glove | |
| | Common Name: | Exam Glove (CFR 880.6250) | |
| | Classification: | Class I | |
| Predicate Device : | | Powder Free Nitrile Exam Glove (K000868) | |
Device Description:
Class I sterile nitrile examination glove, powder free and meeting all requirements of ASTM D3578-99, ASTM 6124-97, and ISO 11137, Part 2, Sterilization of Health Care Products.
Intended Use of the Device:
This is a medical glove to be worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patient.
Technological Characteristics of the Device:
| | ASTM
D3578-99 | Powder Free Colored Blue -
Nitrile Examination Gloves
Nonsterile, K000868 | Powder Free Colored Blue -Nitrile
Examination Gloves Sterile | |
|-------------------------|-----------------------------------------------------------------------|---------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------|------------------------------------------------------------------------|
| Overall
Length: | 230mm
Minimum | 240mm
minimum | 280 mm
minimum | |
| Width: | S: 80mm ±-10mm
M: 85mm±-10mm
L: 110mm ±-10mm
XL: 120mm±-10mm | Small
Medium
Medium-Large
Large
X-Large | Small
Medium
Medium-Large
Large
X-Large | 80mm ±-10mm
90mm±-10mm
105mm±-10mm
111mm±-10mm
120mm±-10mm |
| Palm
Thickness: | 0.08mm minimum | 0.09 - 0.13mm minimum | | |
| Finger
Thickness: | 0.08mm minimum | 0.10 - 0.14mm minimum | | |
| Tensile
Strength: | 14 MPa Before
14 MPa After Aging | 16 MPa Before Aging
14 MPa After Aging | | |
| Ultimate
Elongation: | 700% Before Aging
500% min After
Aging | 700% Before Aging
500% minimum After Aging | 500% minimum before aging
400% minimum after aging
(meeting ASTM D6319 requirements) | |
1
Image /page/1/Picture/0 description: The image shows a logo with a cluster of circles on the left and the words "MOLNLYCKE HEALTHCARE" on the right. The circles are arranged in a way that resembles a flower or a cell structure. The text is stacked vertically, with "MOLNLYCKE" on top of "HEALTHCARE". The logo appears to be for a healthcare company.
Molnlycke Heath Care US, LLC 5550 Peachtree Parkway, Suite 500 Norcross, GA. 30092 Sterile Powder Free, Blue Nitrile Examination Glove 510(k)
| Protein | Zero/Below detection limit using ASTM D 6499 |
|---|---|
| Barrier | Passed ASTM F 1671 |
| Integrity | AQL 0.65 (ASTM D7161) |
| Leak | |
| Acceptance | AQL 0.65 (ASTM D7161) |
Biocompatibility:
In vitro biocompatibility testing was completed by NAMSA to determine the cytotoxic end-point of the test device extract. The results showed that the sterile gloves passed all testing (ISO Closed Patch Sensitization and ISO Skin Irritation).
Microbiological viral penetration testing of protective clothing material intended to protect against blood borne pathogen hazards was also conducted. All acceptance criteria was met for both the negative and positive control samples. The negative control samples were negative for viral penetration, and the positive control samples were positive for viral penetration.
Comparison to the Predicate:
The BioExam Sterile Powder Free Nitrile Examination Glove is substantially equivalent in safety, design and indication for use to the powder free nitrile examination gloves previously cleared under K000868.
Total Residual Powder Content & Presence of Cornstarch:
Residual Powder Content - 0.4-1.6mg/glove Presence of Cornstarch - negative
Clinical Data:
Clinical data is not needed required for gloves.
Conclusion:
The data provided in this 510(k) summary concludes BioExam Powder Free Sterile Nitrile Exam Glove substantially equivalent to the previously clear device under K000868.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The logo is black and white and appears to be a scanned image.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Steve Dowdley Director of Regulatory Affairs Molnlycke Healthcare, Incorporated 5550 Peachtree Parkway, Suite 500 Norcross, Georgia 30092
OCT - 5 2006
Re: K062138
Trade/Device Name: Sterile Powder Free, Blue Nitrile Examination Glove Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: September 22, 2006 Received: September 25, 2006
Dear Mr. Dowdley:
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 prolibitions against misbranding and adulteration.
If your device is classified (see above) into cither class II (Special Controls) or class 111 (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
Page 2 - Mr. Dowdley
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); good mianufacturing 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 Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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,
Cluz
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
4
Image /page/4/Picture/1 description: The image shows a logo with a cluster of circles on the left and the text "MÖLNLYCKE HEALTHCARE" on the right. The circles are arranged in a triangular pattern, with some overlapping. The text is in a simple, sans-serif font, with "MÖLNLYCKE" on the top line and "HEALTHCARE" on the bottom line.
Molnlycke Heath Care US, LLC 5550 Peachtree Parkway, Suite 500 Norcross, GA. 30092 Sterile Powder Free, Blue Nitrile Examination Glove 510(k)
3,0 Indications for Use Statement:
INDICATION FOR USE
Applicant:
Molnlycke Heath Care US, LLC
K062138 510(k) Number:
Sterile Powder Free, Blue Nitrile Examination Glove Device Name:
Indication for Use:
This is a medical glove to be worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patient.
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEBOED) Concurrence of CDRH Office of Device Evaluation (ODE)
| Prescription Use | Or Over-The-Counter X |
|---|---|
| Per 21 CFR 801.109 |
Shule A. Maughy, ho 11/3/06
n of Anesthesiology, General Hospical, Control. Dental Devices
Number 462/38