(211 days)
KGO
No
The document describes a surgical glove and its physical properties and performance against standards. There is no mention of AI or ML technology.
No.
Explanation: The device is intended as a barrier against potentially infectious material and contaminants, which is a protective function, not a therapeutic one. It does not treat, cure, mitigate, or prevent disease.
No
Explanation: The device is a surgical underglove intended to provide a barrier against contaminants, not to diagnose a medical condition.
No
The device description clearly states it is a disposable device made of natural rubber latex, which is a physical material, not software. The performance studies also focus on physical characteristics and biocompatibility.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide a barrier against potentially infectious material and other contaminants when worn on the hands, usually in a surgical setting. This is a physical barrier function, not a diagnostic test performed on samples from the human body.
- Device Description: The description focuses on the material (natural rubber latex), coating, and physical design features of the glove. There is no mention of reagents, assays, or any components used to analyze biological samples.
- Performance Studies: The performance studies listed evaluate physical properties, freedom from holes, biocompatibility, and protein extractables. These are tests related to the glove's integrity and safety as a barrier, not its ability to diagnose a condition.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This glove does not perform any of these functions.
N/A
Intended Use / Indications for Use
The Biogel® OrthoPro® Indicator® Underglove is a disposable device made of natural rubber latex that is intended to be worn on the hands, usually in a surgical setting, to provide a barrier against potentially infectious material and other contaminants.
Product codes
KGO
Device Description
The proposed device, the Biogel® OrthoPro® Indicator® Underglove is manufactured of natural rubber latex. The Biogel® OrthoPro® Indicator® Underglove is manufactured of the exact same material and coated with the Biogel® Coating which is used on the currently cleared device(s) that have been legally marketed by Mölnlycke Health Care for many years.
The glove former design used in the manufacture of this glove allows the Biogel® OrthoPro® Indicator Underglove to provide the user with these additional features:
- . Slightly Curved Former with Independent/Displaced thumb
- Improved Fit, Feel and Comfort (compared to the current Biogel Orthopaedic Surgical Glove)
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hands
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)
No clinical data was required.
Characteristic Dimensions
Physical Properties
Freedom from Holes
Biocompatibility
LAL Test Results
Protein Extractables
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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 878.4460 Non-powdered surgeon's glove.
(a)
Identification. A non-powdered surgeon's glove is a device intended to be worn on the hands of operating room personnel to protect a surgical wound from contamination. A non-powdered surgeon's 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).
0
Image /page/0/Picture/0 description: The image shows the logo for Molnlycke Healthcare. The logo consists of a cluster of four circles on the left side of the image. To the right of the circles is the text "MOLNLYCKE HEALTHCARE" in a sans-serif font.
1101163
NOV-2-3-2010-
Page 40 of 204
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
Biogel® OrthoPro® Indicator® Underglove
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92(c).
Date Prepared:
April 8, 2010
Norcross, GA 30092 Registration number:
Owner/Operator Number:
Applicant:
Official Correspondent:
Trade/Proprietary Name:
Common Name:
Device Class:
Product Code:
Classification Name:
Regulation Number:
Predicate Device Name(s):
Angela L. Bunn, RAC Director, Regulatory Affairs of the Americas Tel: 678-250-7930 Fax: 678-250-7981 e-mail: angela.bunn@molnlycke.com
3004763499
9067000
Biogel® OrthoPro® Indicator® Underglove
Mölnlycke Health Care US, LLC 5550 Peachtree Parkway, Suite 500.
Surgeon's Glove
Surgeon`s Glove
Class I
21 CFR 878.4460
KGO
Biogel® Indicator Underglove (K071565 and K980942) Biogel® Orthopedic Surgical Glove (K071465)
1
Description of Device:
424 HEARE
The proposed device, the Biogel® OrthoPro® Indicator® Underglove is manufactured of natural rubber latex. The Biogel® OrthoPro® Indicator® Underglove is manufactured of the exact same material and coated with the Biogel® Coating which is used on the currently cleared device(s) that have been legally marketed by Mölnlycke Health Care for many years.
The glove former design used in the manufacture of this glove allows the Biogel® OrthoPro® Indicator Underglove to provide the user with these additional features:
- . Slightly Curved Former with Independent/Displaced thumb
- Improved Fit, Feel and Comfort (compared to the current Biogel" Orthopaedic Surgical Glove)
Intended Use/Indication for Use:
The Biogel® OrthoPro® Indicator® Underglove is a disposable device made of natural rubber latex that is intended to be worn on the hands, usually in a surgical setting, to provide a barrier against potentially infectious material and other contaminants.
Technological Characteristics:
The Biogel® OrthoPro® Indicator® Underglove is substantially equivalent to the Biogel® Indicator" Underglove (K071565 and K980942) and Biogel" Orthopedic Surgical Glove (K071465).
All of the assessed devices have similar indications for use, materials, product design, labeling claims and method of operation.
The difference in the proposed device, Biogel® OrthoPro® Indicator® Underglove is the thickness and a slight change to the former.
The Biogel® OrthoPro® Indicator® Underglove characteristics are summarized below as compared to ASTM requirements.
Characteristic Dimensions Physical Properties Freedom from Holes Biocompatibility LAL Test Results Protein Extractables
Standard Meets ASTM D3577 Meets ASTM D3577 Meets ASTM D3577 Meets ISO 10993-1 ASTM D7102 ASTM D5712
Performance Data:
The performance data are summarized above.
.
Page 41 of 204
2
Image /page/2/Picture/0 description: The image shows the logo for Molnlycke Health Care. On the left side of the logo are five circles of varying sizes clustered together. To the right of the circles is the text "MOLNCYCKE HEALTH CARE" stacked on top of each other.
-Clinical Testing:
No clinical data was required.
Conclusion:
Based on the performance testing, it can be concluded that the Biogel® OrthoPro® Indicator Underglove is equivalent to the Biogel® Indicator* Underglove (K071565 and K980942) and Biogel® Orthopedic Surgical Glove (K071465) predicates with respect to intended use, materials, design, and technological characteristics.
Market Barbara Baran Baran Baran The couple the more of the don't Martin Subscription of
Page 42 of 204
3
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Ms. Angela L. Bunn Director , Regulatory Affairs Molnycke Health Care US, LLC 5550 Peachtree Parkway, Suite 500 Norcross, Georgia 30092
NOV 2 3 2010
Re: K101163
Trade/Device Name: Biogel® OrthoPro® Indicator® Underglove with