(86 days)
Not Found
No
The device description and performance studies focus on material properties and barrier performance, with no mention of AI or ML.
No
The device is a surgical gown intended to protect patients and personnel from the transfer of microorganisms and fluids during surgical procedures, not to treat or prevent a disease or condition.
No
Explanation: The device is a surgical gown intended to protect personnel and patients from contamination during surgical procedures, not to diagnose medical conditions.
No
The device description clearly indicates it is a physical surgical gown made of fabric and plastic film, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the surgical gowns are for protecting operating room personnel and patients from the transfer of microorganisms, body fluids, and particulate material during surgical procedures. This is a protective barrier function, not a diagnostic test performed on samples taken from the body.
- Device Description: The description focuses on the materials and construction of the gown, emphasizing its barrier properties and comfort. There is no mention of reagents, assays, or any components used to analyze biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring specific substances (analytes)
- Providing information for diagnosis, monitoring, or treatment decisions based on sample analysis.
The device is a Class II medical device (based on the predicate device K934608, which is a Class II surgical gown) intended for use as a protective barrier in a surgical setting.
N/A
Intended Use / Indications for Use
Medline Disposable Sterile Surgical Gowns, Zoned Impervious are surgical apparel that is intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material.
Product codes
79FYA
Device Description
Medline Disposable Sterile Zoned Impervious Surgical Gowns are manufactured from a non-woven fabric which is laminated to a plastic film. Because the plastic film is made of microporous polyethylene, it provides protection from inward liquid penetration as well as comfort by allowing outward passage of vapor. These products are disposable and intended for single use only.
The Sontara Spunlace Fabric is produced by DuPont. It is a hydroentangled (or hydrolaced) fabric made using a Spunlace technology. For medical applications, the content is approximately 55% wood pulp and 45% polyester. The interlaced fibers and surface finish give Sontara outstanding barrier properties while providing the comfort features of re-usable linens.
This product has seams which are bound to provide strength and barrier properties. Tape is utilized to cover the drill holes required during manufacturing. There are long stockinet cuffs on the sleeves for added comfort and protection. Both Velcro and snaps are offered as closures. The materials used in Medline's gowns are strong, do not unravel or delaminate and are low in lint.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
operating room personnel / surgical procedures
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)
Viral Penetration and Synthetic Blood Penetration Studies. Medline Industries, Inc. Zoned Impervious Surgical Gowns have been tested under both ASTM F1670 (Synthetic Blood Penetration) and ASTM F1671 (Viral Penetration).
Biocompatibility: These devices meet the requirements for biocompatibility per ISO10993 for surface devices, intact skin, limited duration (
§ 878.4040 Surgical apparel.
(a)
Identification. Surgical apparel are devices that are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. Examples include surgical caps, hoods, masks, gowns, operating room shoes and shoe covers, and isolation masks and gowns. Surgical suits and dresses, commonly known as scrub suits, are excluded.(b)
Classification. (1) Class II (special controls) for surgical gowns and surgical masks. A surgical N95 respirator or N95 filtering facepiece respirator is not exempt if it is intended to prevent specific diseases or infections, or it is labeled or otherwise represented as filtering surgical smoke or plumes, filtering specific amounts of viruses or bacteria, reducing the amount of and/or killing viruses, bacteria, or fungi, or affecting allergenicity, or it contains coating technologies unrelated to filtration (e.g., to reduce and or kill microorganisms). Surgical N95 respirators and N95 filtering facepiece respirators are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9, and the following conditions for exemption:(i) The user contacting components of the device must be demonstrated to be biocompatible.
(ii) Analysis and nonclinical testing must:
(A) Characterize flammability and be demonstrated to be appropriate for the intended environment of use; and
(B) Demonstrate the ability of the device to resist penetration by fluids, such as blood and body fluids, at a velocity consistent with the intended use of the device.
(iii) NIOSH approved under its regulation.
(2) Class I (general controls) for surgical apparel other than surgical gowns and surgical masks. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.
0
Medline Industries, Inc.
OCT 2 8 1998
Image /page/0/Picture/1 description: The image shows the logo for Medline. The logo consists of the word "MEDLINE" in a bold, sans-serif font. Above and below the word are two parts of a star shape. The top part of the star is above the word, and the bottom part of the star is below the word.
One Medline Place Mundelein, Illinois 60060.4486
1-847-949-2639 WATS: 1-800-950-0128 Fax: 1-847-949-2643
Lara N. Simmons Director of Regulatory Affairs 510(k) SUMMARY
July 13, 1998
-
- Submitters Information: Medline Industries, Inc. One Medline Place Mundelein, IL 60060 Phone: 847-949-2639 847-837-2787 Fax: Lara Simmons, Corporate Regulatory Affairs Contact:
-
- Device Information:
- Trade Name: Medline Disposable Sterile Zoned Impervious Surgical Gowns A.
- Sterile Disposable Surgeon's Gowns B. Common Name:
- Surgical Gown C. Classification Name:
- 79FYA Class II Device Panel and ProCode: D.
3. Substantial Equivalence Claim: Medline claims substantial equivalence to Johnson & Johnson Medical, Inc.'s Barrier Fabric 450 Surgical Gown, K934608.
4. Device Description:
Medline Disposable Sterile Zoned Impervious Surgical Gowns are manufactured from a non-woven fabric which is laminated to a plastic film. Because the plastic film is made of microporous polyethylene, it provides protection from inward liquid penetration as well as comfort by allowing outward passage of vapor. These products are disposable and intended for single use only.
The Sontara Spunlace Fabric is produced by DuPont. It is a hydroentangled (or hydrolaced) fabric made using a Spunlace technology. For medical applications, the content is approximately 55% wood pulp and 45% polyester. The interlaced fibers and surface finish give Sontara outstanding barrier properties while providing the comfort features of re-usable linens.
This product has seams which are bound to provide strength and barrier properties. Tape is utilized to cover the drill holes required during manufacturing. There are long stockinet cuffs on the sleeves for added comfort and protection. Both Velcro and snaps are offered as closures. The materials used in Medline's gowns are strong, do not unravel or delaminate and are low in lint.
-
- Intended Use:
Medline Disposable Sterile Zoned Impervious Surgical Gowns are surgical apparel that is intended to be worn by operating room personnel during surgical procedures to protect
- Intended Use:
1
Medline Industries, Inc.
Image /page/1/Picture/1 description: The image shows the logo for Medline. The logo consists of the word "MEDLINE" in a stylized, italicized font. Above the word, there is a symbol resembling a compass or a star with four points. The symbol is black, matching the color of the text, and it is positioned directly above the center of the word "MEDLINE".
One Medline Place Mundelein, Illinois 60060.4486
1-847-949-2639 WATS: 1-800-950-0128 Fax: 1-847-949-2643
Lara N. Simmons Director of Regulatory Affairs
both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material.
-
- Technological Characteristics:
There are no technological differences between the new device and the predicate device. They are both made from material that is functionally the same.
- Technological Characteristics:
-
- Non-Clinical Performance Data:
| Feature | Medline | Predicate |
|---|---|---|
| Material | ||
| Composition | Sontara Spunlace – a Non-Woven | |
| hydroentangled (or hydrolaced) | ||
| fabric made using a Spunlace | ||
| Technology | Johnson & Johnson Fabric 450 is a | |
| non-woven hydroentangled fabric | ||
| made using a spunlace technology | ||
| Weight Per Square | ||
| Yard | 1.70 oz/yd² | 2.1 oz/yd² |
| Thickness | 9.4 mils | 10.0 mils |
The safety and effectiveness of Medline Disposable Sterile Zoned Impervious Surgical Gowns are dependent upon proper usage of the product. When used per the instructions, these products provide a barrier to help prevent contamination of the otherwise sterile fields during medical and surgical procedures and provide a protective barrier to help prevent the migration of blood-borne pathogens.
- Viral Penetration and Synthetic Blood Penetration Studies. 8. Medline Industries, Inc. Zoned Impervious Surgical Gowns have been tested under both ASTM F1670 (Synthetic Blood Penetration) and ASTM F1671 (Viral Penetration).
-
- Biocompatibility
These devices meet the requirements for biocompatibility per ISO10993 for surface devices, intact skin, limited duration (